Regulatory Affairs Associate II

Role : Regulatory Affairs Associate II

Work location : Mumbai & Bangalore

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 post-approval 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

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 :

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

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.

Best regards

Ankita