60 Dossier Compilation Jobs

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,....

Job Description Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. Prepare responses to deficiency letters received from various agencies. Maintain life-cycle / post approval changes for drug product registration dossiers. Provide regulatory support to cross functional departments. Prepare and submit scientific advice to various health authorities. eCTD compilation, verification and submission through electronic gateway Review, preparation and submission of annual reports to US FDA Review, preparati...

Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

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...

Role & responsibilities Job Summary: We are looking for a skilled and motivated Senior Executive Drug Regulatory Affairs to support the registration and maintenance of injectable pharmaceutical products across ROW (Rest of the World) markets . The ideal candidate will have experience in compiling and submitting dossiers in accordance with country-specific regulatory guidelines, and will be responsible for handling end-to-end regulatory activities for injectable formulations in semi-regulated and emerging markets. Key Responsibilities: Prepare, compile, review, and submit high-quality regulatory dossiers (CTD/non-CTD formats) for injectable products in ROW markets (e.g., Latin America, Africa...

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products Education PG: M.Pharma in Pharmacy

Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

As a Regulatory Affairs Manager, you will play a crucial role in monitoring the company's production activities to ensure compliance with all applicable regulations and standard operating procedures. Your responsibilities will include devising regulation compliance strategies, creating training and orientation programs for staff, conducting internal inspections and information drives, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of Chemistry, Manufacturing, and Controls (CMC) aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents ac...

Responsibilities 1. To check Artwork for new developed product for Export Market and maintain the record for artworks of packaging materials. 2. To verify all technical documents and information required from QA, QC, Purchase, Marketing, and Production department before compilation of planning of dossier. 3. To prepare and compile registration dossier in CTD, ACTD and Country specific format and submit to concern party. 4. Responsible for query response of dossier.

Formulation Experience Mandatory: Well aware of EU, Australia, Ukraine & UK market requirement Dossier Preparation in ACTD & CTD Format ICH guidelines Communication skills Documents Management Stakeholder Communication

Job Responsibilities: Overall Responsibilities: 1. Compiling all the relevant information necessary to prepare best regulatory dossier (M1 to M5) for registration of a new vaccine or a license update in all concerned row countries including WHO Prequalification. 2. Developing and maintaining the Regulatory Dossier Module 1 to Module 5 keeping the document updated throughout the life of the project/product. Ensuring the coordination with the different areas concerned: Clinical Development, Product Development, Marketing and CMC related functions. 3. Participating and performing change control assessment (CCRs) of any necessary changes and implementation plan with a global view for the impacte...

Role 1: Ecotoxicologist (Zoology Background) Role: Interpret ecotoxicology studies and assessments, focusing on effects on aquatic and terrestrial organisms, birds, NTTP, arthropods (bees). Background: Zoology, ecology, or environmental biology with experience in regulatory ecotoxicology. Expertise : Knowledge about lab and field studies on aquatic (fish, algae etc.)/terrestrial organisms in academics/ previous job. Role 2: Residue & Efficacy Assessment Specialist Role: Evaluate field trials, residue trials and efficacy of plant protection products. Background: B.Sc./M.Sc. in Agriculture, Entomology/Pathology. Expertise: Crop protection, residue and efficacy field trial design, and product p...

Job Title: Regulatory In-charge (Semi-Regulated Markets) Company: GenAide Pharmaceutical Pvt Ltd Location: 909, Satyamev Eminence, Science City Road, Near Shukan Mall, Sola, Ahmedabad, Gujarat 380060 About GenAide Pharmaceutical Pvt Ltd: GenAide Pharmaceutical Pvt Ltd is a young, energetic, and rapidly growing pharmaceutical company committed to delivering high-quality healthcare products. We foster a dynamic work environment with a strong emphasis on teamwork and innovation. Join our already developed team and contribute to our exciting journey! Experience: 5 - 6 years in Regulatory Affairs, with a strong focus on semi-regulated markets. Job Summary: GenAide Pharmaceutical Pvt Ltd is seekin...

Job Criteria: B.Pharm or M.Pharm qualification having experience between 7 - 15 yrs. with dossier filling experience in MEXICO or South East Asian Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skill Job Responsibility: Compilation and review of product license applications, variations, and renewals for Mexico country as per regulatory requirements respectively with minimal supervision Manages electronic documents and creates electronic submissions in CTD format. Preparation and review of responses to authority questions during registration and product lifecycle. Keep track of assigned projects and follow-ups t...

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna. Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement. To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement. Responsible for prepare and review Drug Master File as per respective reulatory agency guidline. Responsible for ensuring that DMF submitting regulatory documentation, maintaning compliance and advising on regulatory strategies. To ensure that Drug Master File (DMF) meet to current respective regulatory agency guideline. Responsible for prepare Drug Master File (DMF) Defi...

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...