Regulatory Affairs Associate II

Work location: Bangalore & Mumbai

Role summary:

• The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filingsboth pre- and post-approvalfor 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 submissionsincluding original applications, amendments, deficiency responses, and postapproval supplementswhile 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

Job 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., , Orange Book) and ensure internal stakeholders are informed of critical changes.
• Participate in audits, inspections, and process improvement initiatives.

Experience & Qualification:

• Masters 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