24 Submission Jobs

Co-ordination with all departments, collection of documents required for regulatory filing, DMF compilation, API document review for adequacy of regulatory submission, supporting activities for business development

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

Experience in US FDA regulatory submission and query response along with handling of Control correspondence. Good Knowledge in Current US FDA Guidelines and MAPP Preparation of Module 1-5, Review and submit through eCTD software. Exposure to 505(j) and 505(b)(2) NCE-1 based submission. Experience in DMF review. Prepare, review, and submit regulatory submissions for Product life cycle management. Collaborate with cross-functional teams (R&D, Quality, Clinical) to ensure regulatory compliance. Develop and implement regulatory strategies to support product approvals and lifecycle management. Monitor regulatory intelligence and assess the impact of regulatory changes on the business. Working knowledge of clinical trial regulations and GxPs. Proficiency in regulatory software or document management systems Please share your CVs @ Kavya.c@viyash.com

Key responsibilities include: Responsible for all Regulatory related activities includes Filing, Submission, responding to DCGI queries, Customer requirements, SUGAM portal registrations, Renewal of licenses, IP commission & CDTL requirements, etc. Responsible to get approvals for the submissions to CDSCO like New drug application, FDC application, Subsequent new drug application, Import license, Test license, etc. Responsible for FSSAI annual returns filing, FosCos online license modification. Responsible for handling PV related activities, which includes PSUR submission and reporting the adverse events of pharmaceutical products for case processing, reviewing & submitting the reports to regulatory authorities. Filing & Submissions: Responsible to prepare submissions to CDSCO like New drug application, Subsequent new drug application, etc. and ensures to respond the DCGI queries & SEC recommendations in timely manner to get permissions/approvals. Responsible to collect & review all the essential documents (API vendor documents, CMC documents, Administrative part, Clinical & Non-clinical data) from CFT for submission. Managing the queries raised by CDSCO against the submitted applications and responsible for addressing the queries & requirements from Indian Pharmacopeia Commission, Central/State Testing Laboratories, SEC committee, DCGI, CDSCO. Regulatory Compliance Management Supports in customer / regulatory complaints, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Ensures that customer / regulatory complaints are adequately handled, including reply to complainant, investigations, corrective and preventive actions and evaluations of effectiveness of corrections. Evaluates, reviews and approves product claim on labels and marketing collaterals in accordance to legal and regulatory requirements. Responsible to organize and archive all regulatory documents including NOC, Product license, NSQs data, AE reports, Drug office requests by co-ordination with site Co-ordinate with the Consultants and Customers on regulatory requirements for new products and major changes in existing products. Reviews proposed changes and its supportive information for completeness and accuracy while ensuring compliance with regulations set by the Central Drugs Standard Control Organization (CDSCO) Responsible for Monitoring of Compendial/ Pharmacopeial revisions or any addition of new monographs, which impacts our system and procedure and ensuring the changes implemented in License, Artwork labelling, specification, testing methods, BMR, BPR, MMR and procedures at all sites Communicate changes in regulatory directions, regulatory intelligence and competitive activities. Notify internally via RA notification as necessary within all relevant regulatory matters Pharmacovigilance Management Responsible for submission of Periodic Safety Update Reports (PSUR) to regulatory authority as a part of new product approval/regularization within stipulated timeline. Responsible for reporting the Adverse Event PV, follow up, coordination with site QA (in case of quality complaint) and provide investigation report to customers and getting the concurrence / approval from customer on investigation and closure. Co-ordinate with CRO for processing AE cases & responsible for reviewing and submitting the reports to regulatory authorities on time. Assisting in PV projects in compliance with customer agreement and local & global regulatory guidelines. Maintain and track all CAPAs & submitted reports related to pharmacovigilance. Ensure pharmacovigilance regulatory compliance with oversight, as needed. FSSAI (Food Safety & Standards Authority of India) To perform & ensures on-time FSSAI annual returns filing (Form ‘D’) periodically. Responsible for central FSSAI license modification by including addition of products time to time and other licensing activities like Free Sale Certificate. Ensures regulatory compliance related to registration of Food Business Operator through Food Safety Compliance System (FoSCoS), Food safety audit, etc. Quality management (NSQ): Co-ordinates with site team & ensure to fulfil the drugs control requirements (Documents/ Sample) of concern FDA/DCD/DTL by responding within stipulated timeline. Collaborate & Coordinate with internal team to make a strategic plan to respond the NSQ/Showcause cases.

Prepare and submit regulatory documents for product approvals, renewals, variations, and notifications. Maintain up-to-date knowledge of regulatory guidelines. Dossier preparation. Support product registration processes. Required Candidate profile 1–3 years of experience in regulatory affairs. Qualification : BSC / MSC / B Pharm Office Location : Mulund

We are seeking a highly skilled and motivated Product Delivery Manager / Program Manager to lead and oversee the development of automotive product line (Preferably BMS, IVI). The Program Manager will be responsible for coordinating cross-functional teams, managing timelines, and ensuring the successful delivery of innovative embedded products that meet safety, regulatory, and performance standards. Key Responsibilities: Project Planning & Execution: Lead the planning, execution, and delivery of automotive embedded systems projects from concept to production including Systems and SW process areas/ subsystems, ensuring alignment with customer requirements, timelines, and budgets. Team Leadership: Manage a multidisciplinary team of engineers, designers, and testers to deliver high-quality embedded system for automotive products (e.g., IVI, BMS). Stakeholder Management: Act as the primary point of contact for internal teams and external stakeholders, including customers, suppliers, and regulatory bodies. Ensure clear communication on project status, risks, and opportunities. Risk Management: Identify, assess, and mitigate risks throughout the project lifecycle, ensuring compliance with automotive industry standards (such as ASPICE, ISO 26262, and cybersecurity). Resource Allocation: Allocate and manage resources efficiently to meet project deliverables, adjust strategies as needed to address challenges in the project lifecycle. Documentation & Compliance: Oversee project documentation, ensure adherence to regulatory and safety standards (e.g., functional safety standards, cybersecurity guidelines). Quality Assurance: Work closely with the QA team to ensure that all deliverables meet industry and customer standards, from early development stages to final validation. Generate metrics as needed. Budget Management: Monitor project budgets, control costs, and ensure the project remains financially viable. Required Qualifications: Education: Bachelor's degree in Electronics Engineering, Computer Engineering, or a related field. Experience: 12-15 years of experience in embedded product development in automotive industry, with at least 3+ years in a program management role within the automotive industry. Technical Expertise: o Strong understanding of Systems and Software development including design and environmental aspects. o Strong understanding of Model based development, MIL, SIL etc. o Strong understanding of BMS, IVI/ ADAS systems. o Strong Knowledge in technical and commercial Prposal submissions. o Strong understanding of automotive embedded systems, including microcontrollers, real-time operating systems (RTOS), communication protocols (e.g., CAN, LIN, Ethernet). o Familiarity with automotive safety standards such as ISO 26262, and process such as ASPICE. Program Management Skills: o Proficiency in program management tools (e.g., Azzure, Microsoft Project, Jira, PPT, Excel, Power BI). o Knowledge of Agile and Waterfall methodologies. o Certification in PMP or PRINCE2 is preferred. Roles and Responsibilities Identifies research and development areas that should be investigated. Responsible for attaining laboratory or department research, marketing, fiscal and staffing goals to conform to organization goals. Establishes operating procedures, practices and guidelines and communicates them with laboratory or department personnel. Establishes, monitors and controls schedules and project budgets. Plans, organizes and manages work of research and support staff. Responsible for negotiation or research contracts. Plans and manages business development and marketing activities for laboratory or department. Develops solutions to complex research problems.

Preparation of: Municipal Drawing / Drafting Challan calculations (PMRDA related task) Filing the necessary documents & file preparation. Letter drafting (all kinds of letters) to authorities: Query solving Covering letters etc. All kinds of drawings: Designing, Sale Plans, Submission, Working Drawings, Detailing of all drawings Periodical site visits Periodical Liasoning visits to PMRDA / PMC Software skills - Autocad, Microsoft office.

To manage and drive the implementation, monitoring, and compliance of all government-sponsored schemes (e.g., PMEGP, CGTMSE, MUDRA, Stand-Up India, etc.) across branches and ensure timely reporting, subsidy claims, and liaison with government agencies Roles and Responsibilities Ensure timely submission of claims for interest subvention/subsidies. Liaise with government departments, SIDBI, NABARD, etc., for approvals and updates. Track scheme-wise portfolio performance, NPA levels, and MIS reporting. Conduct periodic training sessions for branch staff. Prepare and share scheme-specific dashboards and updates with management. Ensure audit compliance and internal controls in all scheme-related operations

ABOUT XENONSTACK XenonStack is the fastest-growing data and AI foundry for agentic systems, which enables people and organizations to gain real-time and intelligent business insights. Building Agentic Systems for AI Agents with https://www.akira.ai Vision AI Platform with https://www.xenonstack.ai Inference AI Infrastructure for Agentic Systems - https://www.nexastack.ai THE OPPORTUNITY We are seeking an enthusiastic Software Trainee Marketing to support campaign management and analyze marketing data. If you are eager to learn, have strong communication skills, and a passion for marketing, we’d love to have you on our team. Job Role and Responsibilities Assist in implementing SEO strategies to optimize website content and improve search rankings. Conduct keyword research and analysis to identify opportunities for content optimization. Collaborate with the marketing team to develop and execute digital marketing campaigns. Help in tracking and analysing key performance indicators (KPIs) for online campaigns. Stay up to date with the latest trends, best practices, and updates in the digital marketing landscape. Support content creation by ensuring it follows SEO guidelines and drives engagement. Assist in the management and optimization of social media platforms and online presence. Skills Requirement Bachelor's degree in marketing, Communications, Business, or a related field. 0-1 year of hands-on experience in digital marketing or internships. Basic knowledge of SEO, keyword research, and content optimization techniques. Familiarity with Google Analytics, SEMrush, or other digital marketing tools is a plus. Strong enthusiasm for digital marketing and staying updated with trends. Excellent written and verbal communication skills. Ability to collaborate in a fast-paced, team-oriented environment. Detail-oriented with a passion for problem-solving and optimization. Familiarity with social media platforms and their marketing potential. Career Growth and Benefits 1) Continuous Learning & Growth Access to certification courses & skill-building sessions for professional development. Exposure to cutting-edge technologies and business analysis strategies. 2) Recognition & Rewards Regular constructive feedback to help you grow. Performance-based incentives and rewards. Special recognition for outstanding contributions and work ethic. 3) Work Benefits & Well-Being Comprehensive medical insurance for health security. Additional allowances for team members assigned to specific projects and Cab facility for women employees. XENONSTACK CULTURE- JOIN US & MAKE AN IMPACT! Here at XenonStack, we have a culture of cultivation with bold, courageous, and human-centric leadership principles. We value obsession and deep work in everything we do. We are on a mission to disrupt and reshape the category and welcome people with that mindset and ambition. If you are energised by the idea of shaping the future of AI in Business processes and enterprise systems, there’s nowhere better for you than XenonStack Product Value and Outcomes - Simplifying the User experience with AI Agents and Agentic AI1) Obsessed with Adoption : We design everything with the goal of making AI more accessible and simplifying the business processes and enterprise systems essential to adoption. 2) Obsessed with Simplicity : We simplify even the most complex challenges to create seamless, intuitive experiences with AI agents and Agentic AI. Be a part of XenonStack’s Vision and Mission for Accelerating the world's transition to AI + Human Intelligence.

THE ROLE Demand for our Functional Service Provision is growing we are therefore looking for a driven and passionate Statistical Programmer to join our reputable FSP team to support one of our fantastic US based pharmaceutical clients. We are looking for an experienced Programmer with ISS / ISE and submission experience, who is versatile and flexible to work on various therapeutic areas. The successful individual must be able to program / QC ISS and ISE datasets, as well as TLFs and will have experience with building macros and standards. This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a pharmaceutical environment. This position is remote, and the successful candidate can be located anywhere in India. Responsibilities: Employees may be required to perform some or all of the following... Program and validate SDTMs and ADaMs, including complex efficacy, labs, etc. Program complex non efficacy outputs/figures Develop and debug complex macros Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies Review simple study design SAP without supervision Review all shells without supervision and provide feedback Knowledge, interpretation and implementation of current SDTM, ADaM standards Knowledge of FDA CRT requirements including define.xml and define.pdf Become familiar with and follow study documentation Ensure the principles in the Phastar checklist are followed rigorously Archive study documentation following instructions in supplied SOPs Act as a Lead Programmer, ensuring quality and timely delivery Liaise with the Study Statistician and Project Manager regarding resourcing and deliverables Assess and monitor study level resources Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Assist in development of internal training courses Qualifications: Educated to BSc or above within Computer Science, Mathematics or a Science related discipline 5+ years of CDISC standards experience (i.e. programming SDTMs and ADaMs) 5+ years of SAS programming experience within the pharmaceutical/CRO industry (essential) ISS/ISE experience (essential) Excellent communication skills Good awareness of clinical trial issues, design, and implementation Familiarity with GCP and regulatory requirements Oncology experience is preferred. APPLY NOW With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in India as this role can be carried out remotely. Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Title We are currently seeking an full time office based Experienced Study Start up Submissions Coordinator to join our Clinical Operations team in India Mumbai. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least 4 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Responsibilities: * Documentation keeping/ printing/ handling/ submission * Ensure timely submissions * Maintain accurate records * Coordinate with clients & vendors & banks & etc

Role & responsibilities Manage billing operations, including cash billing, credit management, and insurance claims processing. Oversee submission of medical bills to various healthcare organizations (insurance companies) for reimbursement. Handle collections from patients or insurance companies as needed. Ensure accurate and timely submission of claims to avoid delays in payment. Coordinate with internal teams to resolve any discrepancies or issues related to billing. Preferred candidate profile 10-15 years of experience in hospital billing, preferably in a leadership role. MBA/PGDM degree from a recognized institution. Strong understanding of hospital management principles and practices. Excellent team handling skills with ability to manage multiple stakeholders effectively.

Roles and Responsibility : To review and arrange required documents to corporate RA for dossiers, query response. To review artwork in artwork management system. R apply product permission, NOC for all manufactured product.R

Key Responsibilities: Strong understanding of eCTD, NeeS, and ICH guidelines. Familiarity with Regulatory systems and Publishing tools. Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint. Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets) Manage lifecycle submissions including variations, amendments, and renewals. Perform document-level publishing, hyperlinking, bookmarking, and validation. Conduct quality control checks to ensure submission readiness. Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical. Stay updated with global regulatory guidelines (ICH, FDA, EMA). Detail-oriented with a collaborative mindset. Minimum Qualifications and Experience B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc. Minimum 4 to 8 years Preferred Qualifications/ Skills Proficiency in managing Regulatory eCTD Submission for all Global Markets. Good knowledge on eCTD Guidance and understanding validation criteria requirement. Strong communication and interpersonal skills. Experience with electronic submission (New Development Product Filings / LCM). Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously. High level of attention to detail and accuracy in document level publishing and submission compilation/validation. Ability to work collaboratively in a cross-functional team environment. Proficiency in using regulatory databases, information management systems, and other relevant software tools. Commitment to staying updated on regulatory changes and advancements in the field.

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD, for submission to the regulatory authority in EU and APAC regions, respectively • Good understanding of clinical trial and product life cycle EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc EXPERIENCE: 4 to 6 years of Regulatory Writing/Reviewing experience LOCATION: Bangalore (Office-based/Hybrid) SKILLS: • Good communication skills (Written and Oral) • MS Office (Excel and Power point) PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES: • Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects) o Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Consent Form [ICF], Investigators Brochure [IB], clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD) o Responsible to run and review literature searches in various databases and screening articles to obtain required information for content development o Good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory content development o Conduct quality checks to ensure the accuracy and consistency of data included in documents o Build expertise in extracting information from textbooks, authentic websites and articles for different deliverables and therapeutic areas o Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism o Follow the best practices while executing projects in the team with regard to processes, communication (internal and external), documentation and technical requirements like language, grammar, style, content search, summarizing, data conflicts and referencing o Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones o Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective • Broad Area-2: Review Content of Team Members o Review the content prepared by junior team members. Validate the authenticity of the content by performing data fact check o Guide team members on content client requirements and quality aspects of content development for different deliverables development (including but not limited to Protocols, IBs, ICF, clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD), o Guide team members to develop content outlines for different target groups that are accurate, clinically relevant, reflecting the most recent medical advances and in accordance with established content development practices, in collaboration with clients and team leads • Broad area-3: Process Adherence and Compliance o Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy o Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client o Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms o Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines • Broad Area-4: Self-Development o Support in developing technical training programs for other team members relevant to the job o Responsible to complete client-specific training, if applicable o Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas o Learn the basic skills to manage teams o Participate in and contribute to various continuous improvement initiatives or company driven initiatives Interested Candidate Please Apply - India.hr@infinitysts.com

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Opening for - Manager, Regulatory Affairs - CMC@ Mumbai , Pune and Hyderabad location. Experience : 5 to 10 Yrs relevant experience in RA CMC This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and were counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Liaise with global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify and communicate potential regulatory issues to GRACS CMC management, as needed Technical Skills: Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance). Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems Leadership Skills: Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Demonstrated effective leadership, communication, and interpersonal skills Qualifications & Skills Bachelors in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry Minimum 5 7 yrs of Industry Pharmaceutical industry experience out of 4 years’ experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics The candidate may be required to travel to other CMO sites on a need basis. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc), preferably in a relevant specialization. Strong understanding of FDA regulations, regulatory operations, compliance, submissions, documentation, guidelines, issues, reports.

Knowledge of registration requirements and procedures in LATAM (e.g., Brazil, Mexico, Argentina, Colombia, Peru, Chile) and other ROW countries (e.g., Africa, CIS, Southeast Asia). Experience with dossier preparation in CTD/ACTD/non-CTD formats. Familiarity with country-specific labeling, packaging. Strong communication, coordination, and documentation skills. Proficient in MS Office, document management tools, and regulatory tracking systems. Dossier Preparation: Compile, review, and submit registration dossiers (CTD/eCTD formats) for domestic and export markets (e.g., ROW, semi-regulated, and regulated markets). Regulatory Submissions: Handle regulatory filings for new product approvals, renewals, variations, and lifecycle maintenance. Labeling & Packaging Compliance: Ensure that product labeling, artwork, and packaging components comply with the regulatory requirements of respective authorities. Communication: Coordinate with R&D, QA, QC, Production, and external partners to gather necessary documents for submissions. Regulatory Intelligence: Monitor and interpret global regulatory requirements and communicate relevant updates to internal stakeholders. Audit Support: Assist in preparation and support during audits and inspections by regulatory authorities. Documentation: Maintain regulatory records, track submission timelines, and ensure completeness and accuracy of submitted documentation. Product Registrations: Liaise with international clients and agents for timely product registration and license renewals. Compliance: Ensure all activities comply with applicable guidelines (CDSCO, USFDA, EU, WHO-GMP, etc.). Role & responsibilities Preferred candidate profile

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

Overview THE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK. Our unique approach to data analysis, The Phastar Discipline, has led us to build a reputation for outstanding quality. With this as our core focus, were looking for talented individuals who share our passion for quality and technical expertise to join our team. WHY PHASTAR Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment. Whats more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, youll also be helping to save the planet! THE ROLE We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including study specific ISS/ISE and DSMB SAPs and output shells with a view to commenting from a programming perspective. Excellent team work ethos, proactive at managing workload, willingness to help others and learn new skills from working in a team environment. This position is remote (although can be office based or hybrid, depending on your location) and will involve occasional travel to events throughout the year. Responsibilities Program and validate datasets and SDTMs, including complex efficacy, labs, etc. Become independent technical expert Program complex non efficacy outputs/ figures Perform Senior Review and Deliver QC of non- statistical output Become involved in developing the standard macro library and take responsibility to implement standard macros within a study Validate and perform User Acceptance Testing (UAT) on standard macros Identify macros requirements, communicate and perform training Create, QC and update complex dataset specifications (including efficacy) for single/ multiple studies, ISS/ISEs, etc. Implement and coordinate development and maintenance of PHASTAR standard specifications Be an SDTM and ADAM expert providing consultancy, advice and training Be an CRT expert providing consultancy, advice and training Be aware of up and coming changes to CRT and define.xml standards and regulatory guidelines and requirements Implement and coordinate the development and maintenance of PHASTAR CRT tools Become familiar with and follow study documentation Initiating projects and ideas for furthering programming development Ensure the principles in the PHASTAR checklist are followed rigorously Develop archiving systems and processes Act as a Lead programmer on multiple studies and project, ensuring quality and timely delivery Liaise with Study Statistician and Project Manager regarding resourcing and deliverables Responsible for study level resources Attend and input to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver company-wide training as and when required Identify areas where new processes are required Create, review and update processes and SOPs Qualifications Ability to lead Able to work on complex programming ISS/ISE experience preferred Have written complex macros. Educated to BSc or above within Computer Science, Mathematics or a Science related discipline APPLY NOW With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment. Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK as this role can be carried out remotely. Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Overview We have an exciting role of Medical Writer to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. Responsibilities Lead and manage a team, providing guidance, mentorship, and support to ensure their professional growth and enhance the quality of output Develop a refined understanding of the brand, disease, and the overall therapeutic/treatment category. Ensure all content is created with appropriate tone, style, and structure based on brand strategy, creative brief, and client expectations Demonstrate a sound understanding of healthcare/pharmaceutical advertising communication requirements Ability to understand appropriate medical/technical documents (clinical studies, product monographs, publications) and translate them into compelling messages and content for a wide variety of audiences Demonstrate superior writing skills and a high level of professional craftsmanship (referencing, annotating) Familiar with modular content and omnichannel marketing - the ability to develop and maintain content matrix and core claims documentation Play the role of a leader when managing a team, exhibit leadership skills and motivate them when required Demonstrate ability to set priorities while handling multiple tasks Keep track resource allocation, and project progress, providing regular updates and reports to management Collaborate with clients and account managers to address feedback, incorporate changes, and ensure client satisfaction Manage multiple projects simultaneously, allocating resources effectively and maintaining effective communication with cross-functional teams and clients Conduct performance evaluations, identify training needs, and provide professional development opportunities for the design team Qualifications 11+ years of experience in healthcare communications agencies (AMA experience is preferred) Bachelor's degree or equivalent experience with a focus on pharma/science/medicine Portfolio containing work samples that demonstrate medical writing for a variety of communication forms (e.g., sales aids, direct mail, websites, social media) for a variety of audiences (e.g., healthcare professionals, patients, consumers) AMA Style Guide knowledge (certification not mandatory) Experience with referencing and annotating, and client MLR submissions requirements An ability to understand and process healthcare information Able to multi-task in a faced paced environment as a member of a highly collaborative team The desire to work with a diverse group of teams, projects, and clients Strong conceptual ability, standout creative thinking, and top-notch writing skills