16 Ema Jobs

Clinical SAS programming Location: Remote Immediate/15 D notice Experience: 10+ years Looking for a candidate who is into Clinical programming and report generation (excluding ADaM, SDTM, and TLF) who will be supporting data management team. (Candidates)clinical programmers play a crucial role in creating accurate reports. However, a significant challenge is that 1 in 3 candidates may be fake. Experience of Creating missing pages, patient profile reports, reconciliation reports Programming: BASE SAS, macros, SQL. Regulatory Knowledge: FDA, EMA, ICH guidelines. Soft Skills: Attention to detail, communication, problem-solving. BASE SAS Certified is Plus candidates should have created SAS reports for DM function.( E.g., missing pages report, reconciliation report, patient profiles etc). Key requirements: 1) SAS Programmers with a minimum of 10 years of experience in clinical SAS programming. Python is good to have skillset. 2) Min 5 years of SAS experience with good understanding of DM and clinical stake holder requirements. Additional details: Responsibilities include (but not limited to) design, development, implementation, and validation of programs created in SAS dashboard applications, to process, analyze and report clinical trial data for review by clinical study teams. Works within established frameworks and ensures high quality is built into own deliverables. Works independently for well-defined scope of work Under guidance, creates catalogue of reports to aid data cleaning activities with moderate scope and medium complexity, but not limited to: Automate manual checks. Automate reconciliation and program edit checks for TPV data to ensure quality. Create tools and repository to minimize data errors at source for collection of lab reference ranges. Program reports to identify missing pages and also detect errors at Subject level. Create reports to measure metrics that can help assess data cleaning status. Create visualizations and dashboards to identify discrepancies in EDC and TPV data. Maintain created catalogue of reports and perform updates based on ongoing changes to requirements. Provide support as required to ensure availability and performance of developed reports and dashboards for both external and internal users Responsible for completion of documentation associated with programming tasks (e.g. peer review, report specifications etc.) in compliance with applicable SOPs Proactively keeps the lead programmers updated on progress of deliveries. Contribute to implementation of cross-functional projects that are part of clinical programming roadmap.

The Strategy & Consulting Global Network Song Practice| Service | Life Science Manager (Level 7) Join our team of Strategy & Consulting Global Network Song who solve customer facing challenges at clients spanning Sales, Service and Marketing to accelerate business change. Practice: Strategy & Consulting Global Network Song I Areas of Work: Life Science, Service transformation, Contact Center, Platform Enablement viz. Vlocity CPQ, Veeva CRM, Salesforce Health Cloud, etc | Level: Manager | Location: Bengaluru, Gurgaon, Mumbai, Chennai, Kolkata Hyderabad | Years of Exp:8 + years Explore an Exciting Career at Accenture Are you passionate about scaling businesses using in-depth frameworks and techniques to solve customer service challengesDo you want to design, build and implement strategies to enhance business performanceDoes working in an inclusive and collaborative environment spark your interest Then, this is the right place for you! Welcome to a host of exciting global opportunities within Accentures Strategy & Consulting Global Network Song practice. The Practice A Brief Sketch The Strategy & Consulting Global Network Song practice is aligned to the Global Network Song Practice of Accenture and works with clients across their marketing, sales and services functions. As part of the team, you will provide transformation services driven by key offerings like Service Transformation, Marketing Transformation, and Commerce and Sales. These services help our clients become living businesses by optimizing their marketing, sales and customer service strategy, thereby driving cost reduction, revenue enhancement, customer satisfaction and impacting front end business metrics in a positive manner. The Life Science Senior Manager position is within the Service practice of Accenture GN Song. The individual would work at the heart of the top global Pharmaceuticals, Biotechnology and Medical Technology organizations and would collaborate on innovative projects while bringing in deep industry knowledge to enhance Patient and HCP experience. You will work closely with our clients as Consulting Professionals who design, build and implement strategies that can help enhance business performance. As part of leading the project teams, you will drive the following: Consulting & Advisory service Lead a team responsible for designing, developing and implementing plans on delivering consulting services that improve service delivery, customer engagement, operational efficiency, and market success. Aid clients to adopt digital solutions to increase their competitiveness and accelerate GTM. Develop and implement solutions to address client challenges , such as improving patient outcomes, optimizing supply chain management, enhancing regulatory compliance, and accelerating product commercialization. Drive the adoption of technology capabilities while ensuring compliance with pharma industry regulations (e.g., HIPAA, GDPR, FDA, EMA) and data security standards. Assist Life Science clients with their most pressing service transformation problems by offering consulting and advisory services. Create a service transformational plan, close the gap between business and technology , and help clients achieve long-term success by co-creating future-proof, agile and resilient operating models. Develop and oversee Life Science components such as care management, patient journeys, appointment scheduling, and data integrations with other systems. Build and maintain client relationships , both existing and new, by understand client problems, bringing relevant solutions and offerings to the clients and influence improvement objectives Provide solutions to complex business problems /opportunities requiring in-depth knowledge of Patient and HCP dynamics, to optimize business processes and deliver on multi-channel customer service strategy. Data and Analytics driven approach highly essential powered by GenAI orchestration for identification and realization of value for the clients and help in driving measurable outcomes through digital investments at the right pace and scale. Recommend and implement digital solutions (e.g., automation, cloud platforms, AI and machine learning tools) to streamline operations and enhance service delivery. Sales & Business Development Generating new business engagements :Drive new business opportunities by identifying and pursuing new leads, defining GTM strategy, facilitate client discussions and presentations to drive new business and client relationships. Work as an integral part of the clients sales / channel development organization. Work towards driving sales and revenue numbers with a structured, logical and dataoriented approach, conducting Market Opportunity. Own and drive Service transformation RFP/RFI response coming in from Life science customers. Practice Development - Strong consulting and advisory experience in Life Sciences industry with deep industry knowledge and understanding of key trends. Take on leadership role: Support overall growth of practice area through a combination of business development, talent management, oversight of delivery work, and thought leadership. Collaborate with Salesforce, Adobe, Nice, MS Dynamics, Genesys etc. business groups, to enable business capabilities with agility, velocity, and quality while optimizing costs. Lead and motivate teams with diverse skills and backgrounds. Manage and mentor talented teams of consultants and technologists supporting, providing input and guidance into the talent strategy and actively participate in engagement, capability development activities. Experience in working as an advisory lead in designing next gen service transformation solution on digital technologies like Vlocity CPQ, Veeva CRM, Salesforce Health Cloud, Data automation and AI tools. Adept with working knowledge of Gen AI based technologies and tools such as ChatGPT, Gemini, DallE, Midjourney, Anthropic, Amazon Bedrock, LLama etc. Capable of using GenAI within applications such as Salesforce, Adobe and MS Dynamics. Understanding on healthcare delivery models, reimbursement systems (e.g., insurance, public health systems), and patient access programs. Bring your best skills forward to excel at the role: Strong consulting and advisory experience in Life Sciences industry with deep industry knowledge and understanding of key trends. Expertise in patient-centric services, healthcare delivery systems, or operational models in life sciences. Deep understanding of Health Care processes, performance drivers & industry leading practices, regulatory and compliance requirements. Understanding of market access strategies for pharmaceuticals and medical devices, pricing and reimbursement, payer negotiation, health economics, and outcomes research (HEOR). Ability to develop long standing relationships with senior client stakeholders. Experienced in managing large global teams, multi-stakeholder environments and complex digital projects engagements in a global network. Strong program management/ people management skills. Experience working with C level executives. Problem solving and conflict management. Ability to work effectively in a remote, virtual and global environment. Read about us. Whats in it for you An opportunity to work on with key G2000 clients Potential to with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your to grow your skills, industry knowledge and capabilities Opportunity to thrive in a that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. Qualification Your experience counts! Minimum 8+ years of relevant experience in Life science industry with good analytical skills along with domain experience. Working knowledge of Veeva CRM or Salesforce Health cloud and AI tools. Implementation experience is a plus. Demonstrated sustained client relations management experience at a C-suite level or operated at a senior management level in the industry role. Familiarity with healthcare technologies such as CRM, Electronic Health Records (EHR), Laboratory Information Management Systems (LIMS), and patient management platforms. Knowledge of allied service transformation capabilities such as speech analytics, workforce management, CX, etc. is a plus. Travel may be required for this role. The amount of travel will vary from 25% to 100% depending on business need and client requirements.

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled with experience in process validation and variation submissions. Your responsibilities will extend to maintaining robust electronic document management systems (EDMS) and ensuring manufacturing records align with regulatory requirements. This position demands a proactive individual with excellent communication skills to effectively liaise with regulatory agencies and internal stakeholders, ensuring Synnat Pharma maintains its commitment to quality and compliance in the pharmaceutical industry. Job Details: Industry: Pharmaceutical (API Division) Department: Regulatory Affairs Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 5,00,000 - 10,00,000 INR per annum Experience: 5-9 years Qualification: Bachelor's degree in Pharmacy, Chemistry, or related field Responsibilities: R egulatory Submissions & Documentation: Prepare, review, and submit comprehensive regulatory dossiers and technical documentation for API products to various health authorities (US FDA, EMA, CDSCO). Manage the compilation, archiving, and tracking of all regulatory documentation using electronic document management systems (EDMS). Ensure all regulatory submissions are accurate, complete, and compliant with current regulatory guidelines and requirements. Maintain up-to-date knowledge of changes in pharmaceutical regulations and guidelines and communicate these changes to relevant stakeholders. Prepare and manage Drug Master File (DMF) filings, renewals, and updates, ensuring timely submissions and compliance. Coordinate with cross-functional teams (manufacturing, quality control, R&D) to gather necessary data and documentation. Regulatory Compliance & Inspections: Lead and manage regulatory inspections conducted by health authorities, ensuring preparedness and compliance. Develop and implement corrective and preventive actions (CAPA) in response to inspection findings and regulatory queries. Conduct internal audits to ensure compliance with pharmaceutical regulations and quality standards related to API manufacturing. Review manufacturing records and analytical data to ensure compliance with regulatory requirements and guidelines. Monitor and ensure adherence to pharmacopeias (USP, EP, BP) and ICH guidelines in API manufacturing processes. Maintain a thorough understanding of API manufacturing regulatory compliance. Regulatory Communication & Liaison: Act as the primary point of contact for communication with regulatory agencies regarding submissions, queries, and inspections. Prepare and manage responses to regulatory queries and deficiency letters, ensuring timely and accurate information. Liaise with internal stakeholders to address regulatory issues and provide guidance on compliance matters. Communicate regulatory updates and changes to relevant departments. Cultivate and maintain positive relationships with regulatory agencies. Provide support and guidance to cross-functional teams on regulatory expectations. Variation & Renewal Management Prepare and submit variation applications for changes to approved API manufacturing processes and formulations. Manage the renewal process for existing regulatory approvals, ensuring timely submissions and compliance. Assess the impact of proposed changes on regulatory filings and ensure appropriate documentation is prepared. Track the status of variation and renewal applications and communicate updates to stakeholders. Ensure all variations and renewals align with current regulatory guidelines. Maintain a comprehensive record of all variations and renewals submitted General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrated experience (6-9 years) in regulatory affairs within the pharmaceutical industry, specifically in API manufacturing. Proven expertise in preparing and managing DMF filings and regulatory submissions for global health authorities (US FDA, EMA, CDSCO). Strong knowledge of pharmaceutical regulations, ICH guidelines, and pharmacopeias (USP, EP, BP). Experienced in regulatory inspections and responding to regulatory queries and deficiency letters. Proficient in EDMS and other relevant documentation systems. Excellent communication, interpersonal, and problem-solving skills with the ability to work cross-functionally.

Job Title: Manager - Sales & Marketing (API) Company: Calyx Chemicals & Pharmaceuticals Ltd Location: Vashi, Navi Mumbai Experience Required: 5 to 9 years Educational Qualification: Bachelor's degree in Pharmacy, Marketing, Business Administration or related field Job Purpose: Responsible for leading sales and marketing of Active Pharmaceutical Ingredients (APIs) by formulating strategies, driving business growth, developing key accounts, managing client relationships, and strengthening brand visibility across global markets. Key Responsibilities: Sales & Business Development: Develop and implement strategic sales plans to achieve revenue targets and market expansion. Identify and capture new business opportunities in domestic & international markets. Build, manage, and strengthen client relationships, ensuring long-term partnerships. Lead key negotiations and close high-value deals ensuring profitability. Coordinate with production, supply chain, and QA/QC teams for timely order fulfillment and regulatory compliance. Represent company at global trade shows, conferences, and industry events to enhance brand visibility. Monitor market trends, competitor activity, and regulatory developments to optimize business strategies. Marketing Strategy and Execution: Design and execute marketing strategies focusing on product differentiation, quality, and compliance. Build and strengthen brand image and visibility in global pharmaceutical industry. Lead digital marketing initiatives (SEO/SEM, social media, content marketing, email campaigns). Monitor effectiveness of marketing campaigns and optimize for ROI. Team Management: Mentor and lead the sales & marketing team to enhance performance and capability. Key Skills & Competencies: Proven track record in driving revenue growth, securing new business, and leading successful marketing campaigns. In-depth understanding of pharmaceutical regulations, API markets, and global regulatory requirements (FDA, EMA, ICH). Experience in international markets and handling regulatory complexities across regions. Leadership and team management skills. Excellent communication, negotiation, and presentation skills. Analytical and data-driven decision making. Customer-centric approach. Initiative, assertiveness, problem-solving, and creativity. Effective planning, organizing, coaching, and mentoring skills. Why Join Us? Opportunity to work with a leading pharmaceutical company. Dynamic work environment with global exposure. Attractive remuneration and growth prospects. How to Apply: Interested candidates may apply through Naukri or email their updated CV to hrd@calyxindia.com About Calyx Chemicals & Pharmaceuticals Ltd: Calyx Chemicals & Pharmaceuticals Ltd is a leading player in the pharmaceutical industry, specializing in the production and marketing of Active Pharmaceutical Ingredients (APIs) across global markets. Write something...

Regulatory Affairs Hiring Profile eCTD Specialist Experience Level: 3 to 6 Years Location: Remote Skills & Qualifications: 1. Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field. 2. Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the pharmaceutical or biotechnology industry. Role Overview: With 3 to 6 years of experience in regulatory affairs, this role requires expertise in eCTD submission software, strong knowledge of global regulatory standards, and the ability to troubleshoot and improve submission processes. The specialist will ensure compliance with evolving regulatory guidelines, provide support and training to teams, and collaborate with clients to meet submission requirements. Technical Skills: o Hands-on experience with eCTD submission software (e.g., Veeva Vault QMS, Lorenz DocuBridge, eCTDExpress etc.). o Strong knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and eCTD formatting standards. o Familiarity with submission systems and document management processes. Soft Skills: Excellent attention to details and organizational skills. Strong communication skills, both written and verbal. Ability to work independently and collaboratively with clients. Problem-solving skills and the ability to troubleshoot technical issues related to client’s eCTD submissions. Key Responsibilities: Develop and manage our own eCTD software tool for the creation, validation, and submission of regulatory dossiers for all the regions. Stay up to date with the latest regulatory guidelines, standards, and requirements related to eCTD submissions. Continuously review and analyze regulatory trends and changes to ensure ongoing compliance and implementation of industry’s best practices. Conduct troubleshooting and resolve any issues related to eCTD submission formats and software functionality for our clients. Provide training and support to Development Team on the use of eCTD tools and best practices. Conduct quality checks on our eCTD tool and ensure they adhere to submission guidelines. Assist in making our eCTD software more robust, user friendly and easy to use. Keep up to date with new regulatory developments and technological advancements related to eCTD submissions and ensure team members are informed. Collaborate with clients to ensure all their submission-related requirements are met for successful filings.

Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.

Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre

Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.

Job Location: Ahmedabad Experience Year : 3+ Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define validation strategy based on risk and regulatory impact. Documentation: Create and review validation documentation including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing. Document test results and deviations. Software Testing as per requirements Internal/ external release. Compliance: Ensure systems comply with applicable regulations (FDA, EMA, GAMP 5). Participate in audits and inspections. Maintain audit trail and data integrity practices. Risk Assessment: Perform risk assessments and impact analyses for changes to validated systems. Change Management: Evaluate system changes and determine need for revalidation. Support Change Control processes. Collaboration: Work with QA, IT, engineering, and business units to support the validation lifecycle. Train users and system owners on compliance requirements. System Lifecycle Support: Manage validation activities through system development, implementation, maintenance, and decommissioning.

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to RD staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

We are looking for an experienced Senior Implementation Specialist with deep expertise in the life sciences industry to lead and execute complex implementations of our technology solutions. This role requires a seasoned professional with over 10 years of implementation experience, strong technical knowledge, and a proven track record in the life sciences domain. The ideal candidate will ensure seamless deployment, integration, and optimization of Freya Fusion, managing both client expectations and regulatory requirements. Key Responsibilities: Project Leadership : Lead the end-to-end implementation of Freya Fusion, overseeing all phases from project scoping and requirements gathering to configuration, testing, and go-live. Client Relationship Management : Act as the primary point of contact for clients, offering expert guidance, managing expectations, and consistently maintain positive relationships to ensure successful adoption of Freya Fusion. Solution Configuration : Collaborate closely with technical teams to configure Freya Fusion according to client specifications, ensuring integration with existing enterprise systems and compliance with industry standards. Data Migration & Compliance : Manage and execute data migration strategies, conducting thorough data validation to ensure accuracy and compliance. Detailed Project Planning : Develop and maintain comprehensive project plans, including timelines, resource allocations, and milestones, while actively identifying and mitigating risks. Regulatory Compliance : Ensure all implementations meet global regulatory standards relevant to the life sciences industry (FDA, EMA, GxP, etc.), maintaining clear documentation for compliance and audit purposes. Client Training & Post-Implementation Support : Conduct training sessions, develop user guides, and provide continued support to clients to facilitate seamless onboarding and system adoption. Process Improvement : Collaborate with internal teams to continuously improve implementation processes, sharing insights to enhance client satisfaction and optimize solution delivery. Required Qualifications: Educational Background : Bachelors degree in Life Sciences, Computer Science, Information Systems, or a related field. Advanced degrees or certifications in Project Management (PMP) or Life Sciences regulatory standards are preferred. Extensive Experience : 10+ years of experience in software implementation (SAAS -Preferred), with at least 5 years focused in the life sciences industry (pharmaceuticals, biotech, MedTech, etc.). Technical Expertise : Strong background in implementing SaaS platforms in regulated environments; experience with Regulatory systems/tools in Life Sciences or similar RIMS or regulatory platforms is highly desirable. Project Management Skills : Demonstrated expertise in project management and handling complex, high-stakes projects, using tools like JIRA, Asana, or MS Project. Regulatory Knowledge : In-depth understanding of life sciences regulations and standards, including FDA, EMA, and GxP requirements. Exceptional Communication and Negotiation Skills : Outstanding client-facing skills with the ability to convey complex technical information to a diverse audience. Problem-Solving & Adaptability : Skilled at troubleshooting and resolving client-specific challenges with a flexible, solutions-oriented approach. Preferred Qualifications: Previous experience with SAAS platforms in Life Sciences or equivalent regulatory and compliance platforms. Proven track record in leading system integrations, data migrations, or configuration management in SaaS environments. Experience working within an Agile framework and Linear Framework

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

My profile - linkedin.com/in/yashsharma1608 Pine Script Developer (TradingView Specialist) Experience: Minimum 2 Years WORK FROM OFFICE - nOIDA IMMEDIATE joiners working days - 5/6 - depending on interview About the Role We are seeking a highly skilled Pine Script Developer with strong TradingView expertise to join our AI-powered trading platform team. Youll be responsible for building, optimizing, and maintaining advanced custom indicators, signal overlays, and script-based strategy tools. Key Responsibilities Develop, optimize, and debug Pine Script indicators and strategies on TradingView Translate AI signals and logic into visual TradingView-compatible overlays Create invite-only and public scripts with clean, efficient visualization Collaborate with data science, UI/UX, and backend teams for integrated deployment Maintain code quality, signal accuracy, and update responsiveness Required Skills 2+ years of hands-on Pine Script experience Deep understanding of TradingView charts, tools, and publishing processes Strong grasp of technical indicators (RSI, MACD, EMA, FVG, Volume, etc.) Experience creating overlays, signals, alert logic, and multi-timeframe setups Ability to translate written trading logic into accurate Pine Script code Preferred (Bonus) Prior work on invite-only or monetized indicators Familiarity with AI signal translation or webhook integration Experience integrating TradingView alerts with external bots or platforms

The ideal candidate will have experience in graphic design with a focus on regulated environments and a strong understanding of pharma-specific packaging components such as labels, cartons, leaflets, and blister packs.

Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 369 b) For Position in Bangalore Search : Job Code # 370 c) For Position in Hyderabad Search : Job Code # 371

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviations and improving efficiency. Conduct technical risk assessments to identify and mitigate potential issues during and post-transfer. Maintain comprehensive documentation to ensure compliance with regulatory standards (e.g., FDA, EMA, cGMP) and internal quality guidelines. Stay updated on regulatory trends and industry standards to continuously improve documentation practices and technology transfer methodologies.