162 Dossier Jobs

POSITION DESCRIPTION: The Quality and Regulatory Affairs (QARA) Specialist will provide leadership in the quality and regulatory affairs function to understand regulatory requirements of medical devices, create relevant documentation and providing consultancy as an expert in regulatory affairs for IZiel clients The RA specialist will work with clients in India and globally across USA and Europe to provide solutions for getting approvals for their products for launch in the Europe and USA The candidate will require to go through extensive training in various country specific regulations as needed to keep themselves up-to-date with the latest and greatest updates as well as represent IZiel at ...

- Develop & Execute regulatory strategies - Stay updated on evolving global regulatory requirements & ensure products comply with international standards - Collaboration with Cross functional teams including R&D, QA, Clinical developments. Required Candidate profile - Strong leadership & management skills, including experience leading cross functional teams - Proven track record of successful regulatory submissions & approvals

JOB DETAILS 1.Review all data and documents related to product registrations for various health authoritiesCompilation of Drug Master Files 2.Registration Dossiers & Technical Data Packages/OpenParts 3.In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation. 4.Prepare responses to deficiency letters received from various agencies for expeditious approval. 5.Preparation of Regulatory Amendments / Variations for smooth API supplies. 6.Provide regulatory support to cross functional departments. 7.Re-position of regulatory database and compliance to procedures FUNCTIONAL AREA Regulatory Affairs Executive jobs in hyderabad, Regulatory Affairs Executive...

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

Preparation, review, and submission of CTD/eCTD/ACTD dossiers, ensuring compliance with ICH, WHO, ASEAN, and country-specific regulatory requirements.

Dear All, We have arranged a Walk-In Interview for Regulatory Affairs (Formulations) - Executive / Sr. Executive where we are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team! (Venue details are given at the end). Experience in Regulatory Affairs is must. Role & responsibilities Preparation of CTD dossiers for Regulated manket [EU/UK/TGA] or ROW market - Asia & Africa market. Experience in handling modules 1 to 5 or atleast 4 & 5 is mandatory. Co-ordination with Plant, R&D & ADL to collect inputs required for Regulatory submission. Variation filling. Timely achievement of monthly plan. Interpretation and timely query response. Education - B.Pha...

Responsibilities. Global Product Registration & Dossier Management Lead the full registration lifecycle (pre-market research, submission, renewal) for all target export countries. Compile regulatory dossiers, including 5-batch analysis and efficacy data, ensuring strict adherence to national formats. Serve as the primary Point of Contact (POC) to coordinate data between R&D, factory, customers, and regulatory authorities for seamless submissions. Compliance and Policy Monitoring Monitor global regulations (e.g., MRLs, restrictions) and communicate changes to ensure continuous company compliance. Verify GLP/quality compliance of all required efficacy, toxicity, and environmental studies prior...

Candidate should be well-versed with Regulatory guidelines, US-FDA, Health Canada, EMA Compilation, review and submission of ANDA, Controlled correspondences, Scientific package to USFDA and responding to queries. Suggest regulatory pathway during development phase for ANDAs. Handling of product life cycle changes and guide cross functional team for filing strategy Review of DMFs., PDR, Labelling and other product related documentation for ANDA. Establishment registration, re-registration, and submitting annual updates

SR. Executive/Assistant Manager/Manager - Regulatory Affairs Roles and Responsibilities - To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries. - To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSC- Procuring and legalization). - To check & approve the artworks for regulated / semi regulated countries. - To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission. -Handling queries pertaining to regulatory submissions from various regulatory authorities. - Maintain re...

Responsible for regulatory activity related to clinical section for US, ;EU, WHO, Canada, Australia, New Zealand and South Africa Markets Preparation of bioequivalence related sections of ANDA product dossiers as per current regulatory guidelines Ensure timely preparation of amendments related to bioequivalence to expedite approvals Review of BE protocol for all market including ROW market Review of bio-waiver information and clinical strategy before start of clinical study. Confirmation of reference product for EU countries for clinical study Review and Preparation of 2.4 (non-clinical review) and 2.5 (clinical review) module for EU submissions Review of SmPC, PIL, Labeling for US, EU and o...

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 , ...

Drug Regulatory Affairs will be responsible for compiling, reviewing, and submitting dossiers and regulatory documents for drug product approvals in international markets. Prepare, review, & submit (CTD/eCTD/ACTD formats) for new drug applications. Required Candidate profile B.Pharm/ M.Pharm in Life Sciences. 2–5 years of experience in Regulatory Affairs Knowledge of national and international regulatory (ICH,WHO,USFDA). Exp with dossier preparation in CTD/eCTD format.

Review and preparation of dossiers (ACTD, CTD, eCTD) as per specific country requirements Preparation and verification of regulatory documents. Candidate Profile:- B.Pharm / M.Pharm / MSc in related discipline. 1-3 years of experience.

1. Regulatory Submissions & Approvals: Prepare, review, and submit drug regulatory dossiers (e.g., Formulations, APIs, supplements) to CDSCO, state FDA, and other authorities . Follow up on approval status, queries, and responses with regulatory bodies. Maintain trackers of pending applications, renewal dates, and approvals . 2. Documentation & Compliance: Ensure preparation of regulatory documents, SOPs, product labeling, packaging inserts, and promotional materials in compliance with regulatory norms. Maintain accurate records of regulatory correspondence, approvals, and submissions . Support internal audits and inspections with regulatory documentation. 3. Product Lifecycle Management: Mo...

Seeking an immediate joiner with 3–8 years’ regulatory experience B.Pharm/M.Pharm. Responsible for CTD/ACTD dossier prep,review,query response,team coordination,regulatory submissions,documentation. Strong R&D,research, communication skills required.

Role & responsibilities Job Description: Responsible for leading and managing all regulatory activities for the Indian domestic market to ensure timely product approvals, license renewals, and compliance with CDSCO and State FDA regulations. Key Responsibilities: Oversee submission, approval, and renewal of product licenses, manufacturing, and marketing authorizations. Ensure compliance with Drugs & Cosmetics Act, Schedule M, and other applicable regulations. Liaise with CDSCO, State FDA, and other regulatory authorities for product-related matters. Review and approve dossiers, product artworks, and labelling as per regulatory norms. Monitor changes in drug regulations and implement necessar...

Sakar Healthcare Ltd incorporated in 2004 has emerged as a leading pharmaceutical manufacturer based in Western India, specialized with innovative oncology solutions. With the research-driven API-integrated EU GMP approved oncology orals & injection formulation manufacturing units, Sakar is ready to cater the global markets with diverse product range and business models. Mentor regulatory team of 12, conduct training sessions on the latest regulatory updates have experience of trouble shooting with good communication skills client handling. Preparing/ checking and submitting technical files and compilation of dossiers in CTD format of Product life-cycle management in ROW & EU markets. Ensuri...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

HA (Health Authority) submissions and regulatory compliances for New Drugs, Line extension, additional indication, production transfer, site registration, renewal, CMC, PI, PSUR to ensure business continuity and support clinical trial projects under GDO and need-based support to other regulatory projects in CPO India To oversee and drive compliance activities within CPO and ensuring maintenance of the same as per stipulated timeline, About The Role Key Responsibilities Compilation and HA submissions of New Drug applications, Line extensions, additional indications along with the site registrations, renewals and production transfer applications for Novartis Pharma products and demonstrate ind...

,in-processthe ,for leading,for leading,problem-solvingResponsibilities We are looking for a senior professional AGM with a range of 15 to 20 years of experience in Analytical Method Validation for regulated markets. The role involves leading API and excipient method validation across multiple dosage forms and managing a team of 30, including three senior managers. The ideal candidate must be technically strong, experienced in US/EU compliance, and hold an M. Pharm, M.Sc., or Ph.D. Role & responsibilities: Accountable to lead the team for AMV of OSD, Nasal, Injectables, Ophthalmic and Topical dosage formulations. Responsible for RM & PM characterization and documentation. Generate qualificat...

Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production departments. Help maintain regulatory databases, tracking sheets , and product registration status logs. Learn and follow current regulatory guidelines (USFDA, WHO, MHRA, EU, CDSCO) . Assist in the submission of post-approval changes , annual updates, and renewal applications. Draft and format regulatory documents, letters, and summaries . Help respond to regulatory agency queries and deficiencies under guidance. Ensure compliance with documentation practice...

Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations. Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements. Regulatory Compliance & Communication Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines. Review and submit annual reports, amendments, variations, and renewals as required. Communicate with regulatory agencies and address queries, deficiencies, and clarifications (Q&A) in a timely manner. Documentation & Data Collec...

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...

The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function. Key Responsibilities: Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes p...