Regulatory Affairs Associate II
3 days ago
Work location:Bangalore & MumbaiRole summary: The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. With moderate to minimal guidance, the Associate II will manage regulatory submissions—including original applications, amendments, deficiency responses, and postapproval supplements—while collaborating closely with cross-functional teams. The role includes evaluating change controls, determining appropriate regulatory pathways (e.g., PAS, CBE-30, CBE-0, AR), confirming the change assessment with their regulatory manager, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. The Associate II, on occasion, will also serve as a regulatory point of contact for assigned products and contribute to process improvement initiativesJob responsibilities: With moderate to minimal guidance, prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach. Work with their manager to support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Support regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing. On occasion, serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc. Monitor and manage regulatory timelines and proactively address data or document gaps. Evaluate and classify change controls for regulatory impact and determine appropriate submission pathways. Compile and submit post-approval changes (PAS, CBE-30, CBE-0, AR) ensuring compliance with FDA, ICH, and internal requirements. Track regulatory guidance updates, stay current with evolving regulatory requirements. Monitor relevant FDA databases (e.g., Drugs@FDA, Orange Book) and ensure internal stakeholders are informed of critical changes. Participate in audits, inspections, and process improvement initiatives.Experience & Qualification: Master’s degree in RA/QA discipline, preferably in Pharma. Minimum 4+ years pharmaceutical industry experiencewith inhalation, implant, ophthalmic, and drug-device combination products;Regulatory, Analytical, QA, laboratory or production experience preferred. Demonstrates an understanding of ICH and FDA guidelines
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Regulatory Affairs Associate
2 days ago
Delhi, Delhi, India Intrinseque Health Full timeThe Regulatory Affairs Associate will manage the preparation, review, and submission of regulatory documents to ensure compliance with applicable regulations. The role will involve monitoring adherence to regulatory requirements, staying updated on relevant guidelines, and providing strategic input on regulatory matters.QualificationsKnowledge of Regulatory...
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Regulatory Affairs Associate
3 weeks ago
New Delhi, India Aurolab Full timeJob Summary:A Regulatory Affairs Associate in the medical device industry supports the development, registration, and compliance of medical devices throughout their lifecycle. This entry-to-mid- level role ensures products meet regulatory standards set by bodies such as the FDA (U.S.), EU MDR (Europe), and other international authorities. The associate works...
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Regulatory Affairs Executive
3 weeks ago
New Delhi, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive : (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
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Regulatory Affairs Analyst
4 weeks ago
New Delhi, India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...
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Regulatory Affairs Analyst
3 weeks ago
New Delhi, India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...
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Regulatory Affairs Manager
4 weeks ago
New Delhi, India Ixoreal Biomed Full timeAbout the Company : Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Regulatory Affairs Executive
3 weeks ago
Delhi, India BKM Health Pvt Ltd Full timeJob Responsibility : Prepare, compile, and review eCTD dossiers for submissions (e.g., ANDA/NDA /MAA/ANDS). Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation. Submit applications to US FDA, HC, EMA, and other authorities in compliance with regional requirements. Compile and validate submissions using...
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Regulatory Affairs Manager
4 weeks ago
Delhi, India Ixoreal Biomed Full timeAbout the Company: Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Regulatory Affairs Manager
4 weeks ago
Delhi, India Ixoreal Biomed Full timeAbout the Company:Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory AffairsExperience:8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal...
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Regulatory Affairs Manager
4 weeks ago
Delhi, India Ixoreal Biomed Full timeAbout the Company :Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory AffairsExperience:8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal...
