67 Ectd Jobs - Page 3

• 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.

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationBangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitting regulatory applications such as permits, licenses, certificates and authorization required by governmental agencies Coordinating government interactions and compliance activities; and interacts with regulatory agencies What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Support the RTB team lead in protecting DB from legal, regulatory and reputational risk with regard to business involving sanctioned entities and / or countries. Ensure diligent review and confirmation of transactions that require escalation to a Level 2 investigator and decide on these in full compliance with the applicable Sanctions regulations and the banks policies and procedures. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Convert timely the update of the relevant embargo lists in respective filtering systems implement the data to central and decentralized tools in GT and Operations. Support CoC Regulatory Filtering team on the adoption of new clients Your Key Accountabilities RTB focus Primarily review stopped messages and take a decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Record rationale for decision from pre-defined set of options. Seek feedback from more senior investigators/reviewers, where their decisions fail the four-eye control. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorised purposes; actively safeguard sensitive and confidential information. CTB focus Supports TSMO / AFC related change projects Supports remediation actions owned by TSMO / AFC Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

UpMan Placements is inviting applications for an exciting career opportunity with one of our esteemed clients from the Pharmaceuticals industry. Role : Senior Manager RA Location : Nagpur / Mumbai Reporting To : Director BD Role Requirement: Regular interaction and close co-operation with R&D, BD, Production and Logistics Responsible for the dossier filling & query responses of EU, Brazil, Canada & Row market Role Responsibilities: Develop and execute regulatory strategies to ensure timely product approvals. Preparation, review & submission of ECTD/CTD dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO Preparation, review & submission of techpack as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for Nutraceutical products Query response raised by (MoH/Customer) to EU, Regulated, and Emerging & ROW of Pharma & Nutra products Documents review QQF, Change control, specifications, Commercial specifications, artworks Process Validation Protocols & Report, Hold time study protocol & report, NDMA reports, Photo stability reports, Elemental reports, Risk assessment, Out of Specification. Co-ordination with external & internal clients. Updation and maintenance of database of dossier status. Fulfil requirement for site registration and GMP clearance/approvals Experience and Background: Bachelors or Masters degree in Pharmacy, Life Sciences, Chemistry, or a related field. 12+ years of experience in regulatory affairs within the pharmaceutical industry. Proven track record of successful regulatory submissions and approvals. Required Skills: Strong knowledge of global regulatory frameworks (FDA, EMA, MHRA, WHO, etc.). Excellent documentation, analytical, and problem-solving skills. Ability to interpret and apply regulatory guidelines and requirements. Effective communication and negotiation skills for interactions with health authorities. Strong project management and leadership abilities. Interested candidates can connect with Vanita at 7861882495 or email at vanita@upman.in

The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for US, Canada and South America

The Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations. You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory information. As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to guide regulatory initiatives, ensuring the smooth adoption of new processes and system use. You will also play a key role in training and developing data standards, ensuring teams are equipped to meet the evolving demands of the regulatory landscape. Your expertise will help shape the future of regulatory operations by streamlining processes and driving compliance across global markets. Roles & Responsibilities: Responsible for maintaining data within the Regulatory Information Management (RIM) system Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system Serve as a Data Management SME within cross-functional collaborative initiatives Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives Provide support on creating, running and analysing reports for data streamline projects Develop and deliver training materials and presentations to a global audience Manage the protocol Amendment New Investigator (PANI) submission updates Manage 1572 forms for FDA submission Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods. Adhere to Amgen processes, policies, guidelines, SOPs and training documentations. Required Knowledge and Skills: Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance In depth understanding of the Veeva Vault system Good written and verbal communication skills Detail oriented Independent time management and prioritization skills Work efficiently with little support and minimal to no supervision Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect Critical thinking skills Appropriate software skills as required Strong analytical and problem solving, communication and presentation skills Good understanding of business complexity and project inter-dependencies Be a great teammate who can work effectively at all levels of an organization with the ability to influence others to move toward consensus Fluent in English, both in oral and written communication Experience in supporting projects / improvement initiatives Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM Be open to working in a dynamic environment embracing change as a constant and adopting new technologies Working in global teams and matrix organizations Able to follow through on tasks and motivate others to meet deadlines Basic Education and Experience: Master’s degree and 1-2 years of directly related experience OR Bachelor’s degree and 2-3 years of directly related experience OR Associate’s degree and 3-5 years of directly related experience OR High school diploma / GED and 5+ years of directly related experience Preferred Education and Experience: Practical experience with CTIS system

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement (CTMME) product team. Build technical solution per implementation project plan by working with various members of the product team and business partners. Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study Support requirements gathering and specification creation process for the development work. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle. Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges/bugs effectively . Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science Bachelor’s degree with 6 - 8 years of experience in Computer Science Diploma with 10 - 12 years of experience in Computer Science. Preferred Qualifications: Solid technical background, including understanding software development processes, databases, and cloud-based content systems. Experience with Python scripting, SQL queries, markup languages (XML, JSON) and familiarity with API-driven content delivery. Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements. Experience with product backlog management (e.g., Jira) and collaboration tools. Good-to-Have Skills: Experience with structured content management, content models, and modular content creation. Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.) Basic understanding of GenAI solutions. Good communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team man a gement. May m anage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development, Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment May manage staff Knowledge and Skills Regulatory CMC- specific regulatory knowledge & experience Staff management and development Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and their timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW and Emerging markets Preferred candidate profile Key Skills: eCTD, CTD, Validation, ICH requirements, USFDA Filings, EMA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products. Must have exposure to in-licensed dossier filing and out licensing Candidates with 6+ years of relevant experience. Candidate must have experience on Bio pharma products

Project Role : Application Support Engineer Project Role Description : Act as software detectives, provide a dynamic service identifying and solving issues within multiple components of critical business systems. Must have skills : Asset Management Good to have skills : Asset Life Cycle Management Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Support Engineer, you will act as software detectives, providing a dynamic service identifying and solving issues within multiple components of critical business systems. Your day will involve troubleshooting, analyzing, and resolving software-related issues to ensure seamless operations. Roles & Responsibilities: Expected to be an SME. Collaborate and manage the team to perform. Responsible for team decisions. Engage with multiple teams and contribute on key decisions. Provide solutions to problems for their immediate team and across multiple teams. Ensure effective communication within the team. Implement best practices for software support. Continuously improve processes and procedures. Professional & Technical Skills: Must To Have Skills: Proficiency in Asset Management. Strong understanding of asset life cycle management. Experience in software troubleshooting and issue resolution. Knowledge of ITIL framework for service management. Familiarity with incident management tools. Ability to work under pressure and meet deadlines. Additional Information: The candidate should have a minimum of 5 years of experience in Asset Management. This position is based at our Gurugram office. A 15 years full-time education is required. Qualification 15 years full time education

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

Preparation & Review of dossier in CTD, ACTD, ETCD format Preparation of dossiers of stability Data, Analytical method validation Preparing the SPC/SMPC as per country guidelines Preparation and Reviewing of documents COA as per the country guideline

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

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting applications like docuBridge Suite from Lorenz and Disclose from Citeline, developing scalable solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime. The ideal candidate will have a strong background in regulatory submissions and clinical trials, along with innovative and transformational experience. Roles & Responsibilities: Take ownership of complex software projects from conception to deployment Manage software delivery scope, risk, and timeline Possesses strong rapid prototyping skills and can quickly translate concepts into working code Provide technical guidance and mentorship to junior developers Contribute to both front-end and back-end development using cloud technology Develop an innovative solution using generative AI technologies Conduct code reviews to ensure code quality and alignment to standard methodologies Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Stay updated with the latest trends and advancements Work closely with the product team, business team, and other partners Design, develop, implement, and maintain applications, including configurations, custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems, and translate them into software architecture and design specifications Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software Work on integrating applications with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently Design and implement systems and processes to improve the reliability, scalability, and performance of applications Develop and maintain monitoring tools and dashboards to track system health, performance, and availability Respond to and resolve incidents promptly, conducting root cause analysis and implementing preventive measures Implement and maintain security measures to protect systems from unauthorized access and other threats What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of Computer Science, IT or related field experience OR Bachelor’s degree and 6 to 8 years of Computer Science, IT or related field experience OR Diploma and 10 to 12 years of Computer Science, IT or related field experience Preferred Qualifications: Functional Skills: Must-Have Skills Have strong eye for business. Can demonstrate a deep understanding of pharma industry regulations and its compliance requirements Have excellent knowledge of submission publishing systems like Lorenz’s docuBridge application and Disclose from Citeline Have knowledge of ClinicalTrials.gov and EudraCT Have good knowledge of Regulatory Veeva Vault Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent. Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Experience in applying technology standard process methodologiesScaled Agile (SAFe), ITIL, etc. Strong knowledge of information systems and network technologies Good-to-Have Skills: Strong knowledge of eCTD specification and highly regulated (GxP) systems Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle of GxP Systems. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytical/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams (preferred) Veeva Vault platform Certified (preferred) Soft Skills: Excellent analytical and solving skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com

Role Description This is a full-time, on-site role located in Ahmedabad for a Regulatory Affairs professional. The role involves preparing and reviewing regulatory documentation, ensuring compliance with regulatory requirements, coordinating regulatory submissions, and staying updated with evolving regulatory affairs. The candidate will work closely with cross-functional teams to support product registrations and regulatory submissions, ensuring adherence to relevant guidelines and standards. Qualifications Experience in Regulatory Documentation, Regulatory Compliance, Regulatory Requirements Knowledge of Regulatory Affairs and Regulatory Submissions in Europe / ROW / Emerging Market Strong attention to detail and excellent organizational skills Ability to work effectively in a team and coordinate with various departments Excellent written and verbal communication skills Familiarity with pharmaceutical industry regulations is a plus Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field Experience Europe Market - 5-8 Yrs Exp ROW/Emerging Market - 4-12 Yrs Exp Interested candidates can share there resume over mail on krupagohil@unisonpharmaceuticals.com

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? contract conversion Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation