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Teva Associate II Complex Gx Regulatory Affairs India, Karnataka, Bengaluru 427121744
Today
The opportunity
- 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 initiatives
How you’ll spend your day
- 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.
Your experience and qualifications
- 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
- Demonstrates excellent verbal and written communication skills.
- Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
- Possesses strong critical and logical thinking.
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