75 Dossier Compilation Jobs

1. Regulatory Strategy & Planning 2. Dossier Preparation & Submission 3. Collaborating with in-market consultant / team 4. Lifecycle Management 5. Compliance & Intelligence 6. Cross-functional Collaboration

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements. Responsible for final review of dossier before submission. To coordinate with technical team for documents required for dossier. Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in acco...

Role Overview: As a Regulatory Affairs Manager, you will be responsible for monitoring the company's production activities to ensure compliance with applicable regulations and standard operating procedures. Your key responsibilities will include devising regulation compliance strategies, creating training programs for staff, conducting internal inspections, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in line with regulatory guidelines, evaluate changes in CMC documentati...

* B.Pharm/M.Pharm with 4-6 years in Regulatory Affairs, experience in dossier preparation, and country-specific formats. * Prepare dossiers, handle queries, manage re-registration and renewal applications.

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Job Description/ Capsule For assigned products: Regulatory strategy for NCE, Acceleration process Plan to gain rapid and high-quality approvals and ensure high standard of regulatory compliance, SEC Preparation, in order to achieve the company's business objectives. Developing India specific Artwork, Support to Regulatory dossier preparation and Submission like New drug application, Site ...

1. Drug Regulatory Affairs - Job description Prepare CTD, ACTD Dossiers and file regulatory submissions Perform assessments of new or revised products Manage complaint documentation (including investigation and closure) Respond to inquiries from regulatory bodies Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines To Coordinate with relevant department for arranging documents To prepare / compile dossier for allocated products / countries To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc To coordinate with courier agency for dispatches of dossier /samples To make timel...

Role Overview: As a Regulatory Affairs Manager, your main responsibility will involve monitoring the company's production activities to ensure compliance with relevant regulations and standard operating procedures. You will be tasked with devising strategies for regulation compliance, organizing training programs to educate staff on policies and standards, conducting internal inspections and awareness campaigns, and staying updated on the latest rules and regulations in the industry. Key Responsibilities: - Demonstrate expertise in CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in adherence to ...

Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives : Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department. 1. Dossier Preparation and Review Oversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with regulatory requirements. Review dossiers prepared by team members to ensure they meet national and international standards. Provide guidance and technical expertise to the team during dossier preparation. 2. Regulatory Submissions and Approvals Manage applications for licenses, permissions, and other regulatory approvals in the country o...

Responsibilities: CTD/ ACTD Process Validation (PV) BE Study Stability PDR Art work Check BMR/BPR Preparation SMPC Leaflet flit Preparation (Insert) AMV CDP Match Spect COA/MOA Finish Specifications Self-Prepared and Review

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format preparation. Coordinate with cross-functional teams (QA, QC, Marketing) to obtain necessary documents for dossier compilation. Ensure compliance with regulatory requirements by reviewing documents such as SOPs, protocols, reports, and batch records. Review and compile dossiers according to client specifications and timelines. Maintain accurate records of all activities related to dossier compilation. Desired Candidate Profile 2-4 years of experience in Regulatory Affairs or a related field (B.Pharma / M.Pharma). Strong knowledge of drug regulatory affairs in the Row market (European region). Pro...

ear Candidate, We are seeking a Senior Executive/ Assistant - Regulatory affairs Europe) to join our team, He/ she will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approvals. based at Govandi Location. Markets : Europe Dosage Form : OSD/ Sterile Key Responsibilities: Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products to get licenses from various targeted markets. Prepare the checklist for documentation for regulatory filings as per current regulatory requirements (country specific). Collate and conduct first-level review/overview of relevant standard technical documentation like stability, TTD, ...

Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier c...

Roles & Responsibilities Regulatory Submissions & Filings Prepare, review, and submit DMFs, CEPs, and regulatory dossiers for API registration in global markets (USFDA, EMA, WHO, etc.). Ensure submissions are complete, accurate, and in CTD/eCTD format. Coordinate with internal teams to gather technical and manufacturing data for filings. Track submissions, approvals, and queries from regulatory authorities and ensure timely responses. Dossier Preparation & Maintenance Prepare and maintain dossiers in compliance with current regulatory standards and GMP requirements. Update existing dossiers to reflect process or analytical changes. Review and compile CMC (Chemistry, Manufacturing & Controls)...

Job Description We are looking for an experienced Regulatory Affairs Manager to manage and oversee regulatory submissions and compliance for Emerging or ROW (Rest of the World) markets . The role requires in-depth knowledge of international registration requirements, dossier preparation, and life-cycle management of pharmaceutical products. Key Responsibilities Manage regulatory submissions, approvals, and renewals for Emerging & ROW markets (Asia, Africa, Latin America, CIS, Middle East, etc.). Prepare, review, and compile CTD / ACTD dossiers for new product registrations. Coordinate with R&D, QA, QC, and Production teams to gather technical data and ensure dossier readiness. Maintain and u...

Industry: Pharmaceutical Location: Chembur East, Mumbai About the Company: A reputed pharmaceutical organization with over 75 years of excellence in the healthcare sector. Renowned for pioneering the introduction of life-saving critical care molecules and vaccines in India, the company is committed to innovation and delivering quality healthcare solutions nationwide. Working Days & Hours Working Days: Monday to Saturday (2nd & 3rd Saturdays Off) Working Hours: 10:00 AM to 7:00 PM Job Title: Regulatory Affairs Location: Chembur East Industry: Pharmaceutical Key Responsibilities Regulatory Expertise: Oversee regulatory processes for pharmaceutical finished formulations across CIS, LATAM, and A...

Responsibilities: * Prepare regulatory dossiers for product approvals * Collaborate with cross-functional teams on dossier updates * Ensure compliance with drug regulations according to NAFDAC standards. * Manage LOAs, COAs & BDNAF submissions

Responsibilities: Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions. Handle full lifecycle of product registration including new submissions, renewals. Review technical documentation: PDR, DMF, AMV, BMR/BPR, Specifications, Stability Reports, BE Studies, etc. Address Ministry of Health (MoH) queries and manage deficiency responses. Manage post-approval changes and variation submissions. Liaise with international regulatory agents and distributors for submission coordination. Artwork review and approval ensuring compliance with label regulations. Maintain up-to-date registration database and submission tracker....

You will be responsible for the following tasks: - Preparation and Compilation of ACTD, CTD, and country specific dossiers for products to be submitted in ROW Market - Preparation of query responses for the dossiers - Reviewing technical documents such as BMR, Specification, Method of analysis, COA for Raw material, packing material, and finished product - Preparation and review of the artwork technical details - Maintaining technical documents for the products - Maintaining FDA license documentation including Product permission, CoPP, FSC, and related expenses - Keeping track of documents sent for notary and legalization In addition to the listed responsibilities, other tasks may be assigne...

Roles and Responsibilities (5 days working) Dossier (CTD, ACTD & Country Specific Format) review for Latam, ASEAN, CIS & African countries. Collaborate with various departments within the organization, such as Plant (QA, QC, Production, Packing & Purchase) and R&D, to gather the necessary inputs for regulatory submissions. Compilation and timely submission of Dossiers to the respective regulatory authorities in the assigned countries. Planning, monitoring, review, strategy & delegation of the below mentioned activities for Countries: New Product Registration, Re-Registration, Retention, Tender. Handling of queries from various regulatory authorities/consultants. Post Approval Changes GMP (Co...

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats. Responsible for final review of dossier before submission. Reviewing artwork for products as per relevant regulatory authority requirements. Coordination with F&D, QA, QC & Store for documentation In-depth knowledge of pharmaceutical documentation & regulatory guidelines. To coordinate with technical team for documents required for dossier. Country Experience Preferred: CIS, LATAM Dosage Form Experience: Soild Oral + Injectable Preferred candidate profile

Roles and Responsibilities (5 days working) Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets. Handle team responsibilities related to dossier compilation, review, and approval. Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the organization. Collaborate with cross-functional teams to ensure timely completion of tasks and meet project deadlines. Provide expertise in ASEAN, LATAM markets Team Handling, and Dossier Preparation. Desired Candidate Profile M.Pharma degree from a recognized university with 10-12 years of experience in drug regulatory affairs. Strong understanding...

Job Title Executive Regulatory Affairs Business Unit R&D1 Regulatory Affairs Job Grade G12A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Job Description Compilation , review of dossier for US , EU , AU, C...

1. Regulatory Affairs: - o Prepare, compile, and submit regulatory dossiers (e.g., CIBRC, CDSCO, EU, etc.) for registration of agrochemical, disinfectants, biocide and food contact material products. o Liaise with client and regulatory authorities for approvals, clarifications, and queries. o Maintain up-to-date knowledge of regulatory requirements in India and international markets. o Support risk assessment and labeling compliance for products. 2. Toxicology & Safety Evaluation: o Review and interpret toxicology, Endocrine disruptors and ecotoxicology study reports. o Coordinate with external labs/CROs for conducting toxicological and ecotoxicology studies. o Maintain regulatory and toxico...

Job Description Position Summary We are seeking a Senior Officer- Regulatory affairs (US Markets ) to join our team, he will be reporting to Deputy General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approval Key Responsibilities: Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products to get licenses from targeted markets. Prepare the checklist for documentation for regulatory filings as per current regulatory requirements (country specific). Collate and conduct review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations, E...

Responsibilities: * Collaborate with cross-functional teams for documents and dossier compilation * Ensure compliance with regulatory guidelines & standards * Documentation. calibration, validation,....