88 Dossier Preparation Jobs - Page 3

Regulatory Strategy & Planning Submissions & Approvals Team Leadership & Governance Global Compliance & Maintenance Cross-Functional Collaboration External Stakeholder Management

1. Preparation and review of Drug Master Files, Dossiers as per regulatory guidelines. 2. Ensuring compliance with regulations set by the authorities. 3. Keeping up to date with changes in regulatory legislation and guidelines. 4. Analyzing complicated information & data provided by other departments, including trial data. 5. Ensuring that quality standards are met and submissions meet strict timelines. 6. Coordination with QA, QC & R&D to get documentation required for preparation of Drug Master Files & Technical dossiers. 7. Responsible for DMF/Dossier updations, revisions. 8. Responding to Customers and Regulatory Authorities on technical queries in time. 9. Maintaining customer correspondences.

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other regulatory bodies. Filing application of ND/SND/FDC/Import Registration/Import license etc. on SUGAM portal. Track and interpret evolving regulatory requirements and assess their impact on ongoing projects. Collaborate with marketing and business development to support go-to-market strategies, portfolio expansion. Compliance & Change Control: Ensuring that manufacturing processes meet all relevant regulations and guidelines. Assessing and managing the regulatory impact of changes to manufacturing processes. Review of technical documents, Change controls Gap analysis for variation filing and maintaining product Life cycle. Collaborating with cross-functional teams, such as R&D, QA, and manufacturing, to ensure regulatory compliance. Audits and Inspections: Preparing for and supporting regulatory audits and inspections across various contract manufacturing sites. Ensuring that corrective actions are implemented in a timely manner with respect to Audit findings and that any necessary documentation is updated in a systematic manner. Others: Staying up-to-date with current FDA / FSAAI regulatory requirements and guidelines for APIs and Finished formulations. Provide regulatory support to QA-AC for IPC/CDTL/CDL testing Providing regulatory support for new product development. Key Result Areas: Manage proactive and professional delivery of results for the regulatory activities of all the products to support the business goals Ensure a high scientific standard and quality for all regulatory documents Monitoring and ensuring that both API manufacturing and Finished formulations production adhere to all applicable regulations. Preferred candidate profile B-Pharma or M-Pharma Minimum of 8 to10 years of experience in regulatory affairs in pharmaceutical industry, With at least 3 to 4 years in a managerial role. Strong understanding of pharma regulatory framework. Excellent communication and multi-tasking skills Location Mumbai HO / Regular visits to various Contract Manufacturing sites Department Regulatory Affairs

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.

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific discipline Diploma in Regulatory Affairs preferred Technical and Professional Expertise Demonstrated experience in regulatory affairs with a focus on submissions for the US, EU, UK, and Emerging Markets Solid understanding of ICH guidelines, ASEAN CTD requirements, and eCTD publishing standards Practical experience in the preparation, review, and submission of regulatory documents Familiarity with Quality by Design (QbD) principles and data trend analysis Experience 5 to 10 years of relevant experience in regulatory affairs Key Personal Attributes Excellent verbal and written communication skills Strong interpersonal and collaboration abilities Capable of working independently and managing multiple projects simultaneously Domain and Functional Competencies In-depth knowledge of international regulations (e.g., FDA, EMA, ICH) Up-to-date with evolving regulatory frameworks and compliance requirements Proficient in compiling,reviewing, and submitting comprehensive regulatory dossiers Ensures completeness, accuracy, and adequacy of all documents required for product approvals

Job Summary: We are seeking a Regulatory Affairs Specialist with 4 to 8 years of experience in compiling, preparing, and submitting regulatory dossiers in accordance with European regulations (EMA/EU). The ideal candidate will have a proven background in injectable drug products and will ensure regulatory compliance throughout the product lifecycle, working closely with cross-functional teams and regulatory agencies. Key Responsibilities: Prepare, compile, and review regulatory submissions for the EU region, including CTA, MAA, Variations, Renewals, and PSURs/DSURs. Ensure dossiers comply with EMA and national regulatory authority requirements, including eCTD/NeeS formatting. Maintain product registrations and ensure timely submission of updates, renewals, and amendments. Liaise with internal departments (e.g., R&D, Quality, Clinical) to collect and verify data for regulatory submissions. Respond to queries from European regulatory agencies and prepare responses to deficiency letters. Monitor changes in EU regulatory requirements and assess the impact on products and documentation. Contribute to regulatory strategy development during all phases of the product lifecycle. Manage electronic submission tools and regulatory databases. Assist in audits and inspections to support compliance with regulatory expectations. Required Qualifications: Bachelors or Masters degree in Pharmacy, Life Sciences, or a related field. 4–8 years of hands-on experience in EU regulatory dossier preparation and submissions. Experience in regulatory submissions specifically for injectable drug products is mandatory. Strong knowledge of EMA guidelines, EU regulations (including 2001/83/EC and 2017/745 for medical devices if applicable). Experience with eCTD software and publishing tools. Understanding of regulatory procedures: CP, DCP, MRP, and national submissions. Excellent written and verbal communication skills. Strong project management and organizational abilities. Preferred Skills: Experience in a CRO, pharmaceutical, or medical device company. Knowledge of regulatory requirements beyond the EU (e.g., UK MHRA, Swissmedic). Experience with regulatory intelligence tools and databases.

Role & responsibilities We are seeking a detail-oriented and knowledgeable Executive Drug Regulatory Affairs to manage the preparation, compilation, submission, and post-submission activities related to herbal formulation dossiers for domestic and international regulatory authorities. The ideal candidate should have a strong understanding of herbal product regulations, excellent documentation skills, and the ability to manage regulatory queries effectively. Key Responsibilities: Prepare, review, and compile regulatory dossiers for herbal medicinal products in compliance with country-specific regulations . Ensure that all documents are accurate, complete, and meet submission timelines. Coordinate with cross-functional teams including R&D, Quality, Manufacturing, and Marketing to gather required data and technical documents. Submit regulatory dossiers to appropriate health authorities and track submission status. Respond to regulatory queries promptly and effectively with appropriate justifications and additional documentation. Keep up to date with evolving regulatory requirements for herbal and traditional medicines across various markets. Maintain regulatory databases, submission trackers, and ensure documentation compliance with internal and external standards. Assist in the preparation of product labels, artworks, and promotional materials from a regulatory compliance perspective. Qualifications and Skills: Education: B.Pharm / M.Pharm / M.Sc. (preferably in Pharmacognosy, Pharmaceutical Sciences, or a related field) Experience: 2–5 years of experience in Regulatory Affairs with specific focus on herbal or traditional formulations . Familiarity with regulatory frameworks such as AYUSH , WHO-GMP, ASEAN Guidelines, EU Traditional Herbal Medicinal Products Directive, etc. Excellent written and verbal communication skills. Proficient in MS Office (Word, Excel, PowerPoint). Strong attention to detail and organizational skills. Ability to handle multiple projects and deadlines. Preferred candidate profile

Roles and Responsibilities Prepare dossiers for regulatory submissions, including compilation of data from various sources into a cohesive document. Review and compile dossiers prepared by others to ensure accuracy and completeness. Coordinate with internal departments (e.g., CMC, Non-Clinical Toxicology) and external vendors/consultants to obtain necessary information for dossier preparation. Ensure timely submission of dossiers to relevant authorities (e.g., FDA, EMA). Maintain accurate records of all correspondence with regulatory agencies. Desired Candidate Profile 5-8 years of experience in Regulatory Affairs or related field (B.Pharma / M.Pharma degree required). Strong understanding of drug regulatory affairs, particularly in Europe market. Proficiency in compilation, dossier preparation, and regulatory submissions.

Role & responsibilities : Lead Regulatory Affairs department. Should be well versed with submission of Document in CTD/ACTD Format for Regulatory & ROW Market. Should be able to handle team. Preferred candidate profile Reputed Pharma background.

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.

Dossier Preparation. Interact with Marketing, Quality Control, Product Development, R&D, & manufacturing units to collect necessary documents. MSDS of both Technical & formulation products. Discussions with regulatory team to improve knowledge. Required Candidate profile Must have exp in international regulatory affairs.

We are seeking an experienced Regulatory Affairs professional to support and manage the regulatory lifecycle of oral solid dosage (OSD) products across key global markets, including the EU, USA, and RoW.

Dossier Preparation. Interact with Marketing, Quality Control, Product Development, R&D, & manufacturing units to collect necessary documents. MSDS of both Technical & formulation products. Discussions with regulatory team to improve knowledge. Required Candidate profile Must have exp in international regulatory affairs.

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

Roles & Responsibilities: Study of project specifications, instrumentation engineering specifications, and design of electrical control systems. Preparation of single line diagram, instrument datasheets, and thyristor datasheet in compliance with project specifications and industrial standards. Evaluate vendor quotations for technical specifications and scope clarity as per project requirements. Preparation of electrical engineering documents in support with vendor and upload online for approval. Preparation of inspection reports and inspection dossiers. Conduct technical discussions with the engineering team, vendors, and customers to obtain approvals for engineering documents. Execute stage inspections and expedite manufacturing of control panels as per project timelines. Provide technical support during installation and commissioning at the customer site. Provide technical support for resolving customer complaints. Prepare as-built engineering documents in collaboration with vendors and complete final project documentation. Maintain all design documents in compliance with ISO standards. Qualification & Skills Required: Minimum 68 years of experience working in the control panel manufacturing industry. Graduate degree in Electrical Engineering or Control Systems Engineering. Proficient in electrical engineering drafting using AutoCAD Electrical or E-Plan. Experience in control panel manufacturing industry is preferred.

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan and Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

Key Responsibilities will include : 1) Experience in technical review and compilation of registration dossiers for regulated markets. 2) Review of master documents (Specifications, MFR, BMR, BPR, PVP, PVR, HTSP, HTSR, PDR, elemental impurity risk assessment, nitrosamine risk assessment, stability protocols), DMF. 3) Deficiency management for products filed to regulated markets.

Process/Sub-Process Responsibilities/Activities: Must have experience in international regulatory affairs, pesticide regulatory activities in overseas countries. Registration Requirements: Study the registration requirements in each country from time to time Identify the data availability from database and prepare gap analysis Dossier Preparation: Prepare the dossiers in prescribed format Document Preparation: Understand Global Harmonization System and prepare MSDS of both Technical and Formulation products Prepare other dossier related documents like Composition, Authorization letters, Specifications, labels and leaflets etc., as per regulations of each country Data Scouting: Find authentic data on Chemistry, Toxicity, Eco toxicity, Efficacy, Residues, and MRLs or any other information from public domain on active ingredients, and formulations Discussions: Internal discussions within regulatory team to improve knowledge and implement suggested strategies. Collaboration: Interact with Marketing, Quality Control, Product Development, R&D, and Manufacturing units to collect necessary documentation like Analytical Methods, COAs, MSDS, Label, leaflet etc., and samples from time to time

Knowledge on Regulatory guidelines for API & Finished product registration. Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets. Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling of customer and MOH queries. Coordination with cross-functional teams & Reviewing of Documents (Specification, MOA, 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. Should have hand on experience in handling ODLS, FSSAI, Sugam Portal for Licensing of Drug & Food Products. Prior knowledge on Administrative document applications (COPP, GMP, Free sale and Import License). Registration information management system updates on regular basis. Requirements Bachelors/Masters degree in Biotechnology/ Microbiology/ Pharmacy/ Regulatory Affairs. 1-4 Years of experience as Regulatory Affairs Executive in Pharmaceuticals. Interpersonal and communication skills Planning and organizing skills

Elevate Your Career with us, we're Seeking Masterminds to Drive Excellence! Evolet Healthcare Pvt. Ltd. is hiring for the position of Sr./Executive- Drugs Regulatory Affairs. Job Description: Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. Controlling the whole process of registration products from the beginning till the end. Evaluation of Bioequivalence and Clinical Trials (preferably). Required Candidate profile: Having knowledge of ICH guideline with relevant 1-5 years of experience. Having experience in registration any CIS, ASEAN, LATAM and AFRICAN countries. To be flexible for travelling and meeting with manufacturing plant representatives, which located out station. Must have excellent communication skills Must have excellent in analyzing skills Excellent in accuracy and focus Self-motivated and enthusiastic Perks and Benefits: Health Insurance Shuttle facility, Fix office timing, Career growth training & development

Role & responsibilities B.Pharma / M.Pharma candidates with 12--15years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle. Preferred candidate profile Reputed Pharma background

Dossier preparation as per CTD/ACTD/eCTD/Regional guidelines. To co-ordinate with plant team i.e. QA, QC, Production department for availability of technical & legal documents in the given time-line. Review of documents received from plant team and co-ordinate with respective departments in case of any discrepancies. Review of dossiers prepared by team-mates. To ensure that the registration samples be available as per pre-defined time-frame. Submission of response to Queries / Deficiencies raised by Customers / Regulatory Authorities within timeline. Artworks review & approval Co-ordination with Clients / Customers for the registration updates, plant approval process etc. To maintain & update the records for all submissions & regulatory related activities

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.

Role & responsibilities Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations : a. Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc Note:- We are specifically looking for professionals with prior experience in US/EU Market.

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name