Regulatory Affairs Associate II
5 hours 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 experience with 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 II
15 hours ago
Bengaluru, India Teva Pharmaceuticals Full timeWork 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...
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Regulatory Affairs Associate II
4 hours ago
Bengaluru, India Teva Pharmaceuticals Full timeWork 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...
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Regulatory Affairs Associate II
16 hours ago
Bengaluru, India Teva Pharmaceuticals Full timeWork location: Bangalore & Mumbai Role 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,...
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Regulatory Affairs Associate II
15 hours ago
Bengaluru, India Teva Pharmaceuticals Full timeWork 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,...
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Regulatory Affairs Associate II
35 minutes ago
Bengaluru, India Teva Pharmaceuticals Full timeWork location: Bangalore & Mumbai Role 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,...
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Regulatory Affairs Associate
3 weeks ago
Bengaluru, India ANRGI TECH Pvt. Ltd. Full timeJob Description Job Title: Regulatory Affairs Associate – Authoring. Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring...
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Regulatory Affairs Associate
3 weeks ago
Bengaluru, India ANRGI TECH Pvt. Ltd. Full timeJob Title: Regulatory Affairs Associate – Authoring. Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring and/or other...
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Regulatory Affairs Associate
7 days ago
Bengaluru, India Parexel Full time**_Regulatory Affairs Associate _**: **Experience: RIM**: **Relevant experience in Regulatory and should be willing to work in EU Shifts (12:00 - 9.00 PM)**: - **Experience of handling RIM tools - Veeva Vault specifically.**: - **Basic Regulatory knowledge on regulations and Health Authorities.**: - **Excellent communication skills.** **Knowledge and...
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Regulatory Affairs Analyst II
4 weeks ago
Bengaluru, India Waters Corporation Full timeOverview The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to prepare, execute and maintain regulatory filings including change management, support of post market requirements and support of outside vendors (e.g. license holders, in country representatives). Secondary responsibility would...
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Associate Regulatory Professional Ii
24 hours ago
Bengaluru, Karnataka, India Novo Nordisk Full timeAssociate Regulatory Professional II **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**:EU Submissions Hub- Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living...
