202 Dossier Preparation Jobs - Page 7

Role & responsibilities - Dossier preparation, review and submission in ACTD/CTD/ Country specific formate and also in ROW. - Review of technical documents - Responding to dossier - related queries. - License related activity. - Strong coordination with functional related department. Preferred candidate profile Dossier Preparation, Submission, Technical Review

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 correspon...

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 re...

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, Chemis...

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 produc...

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. Coordi...

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 o...

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 stag...

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 Sea...

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...

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 OD...

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 representat...

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 & updat...

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 o...

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. Prep...