Senior Manager Regulatory Affairs- EU/US

Manager – Regulatory Affairs (US / EU)

Location: Gurgaon, Haryana, India (Onsite)

Role Overview

The Manager – Regulatory Affairs (US/EU) will lead regulatory strategy, submissions, and compliance for pharmaceutical products intended for the US and EU markets. This is an onsite role based in Gurgaon. The individual will serve as a key regulatory liaison, ensuring products meet all regulatory requirements, supporting lifecycle management, and facilitating timely approvals by the relevant authorities.

Key Responsibilities

•Develop regulatory strategies for product development, registration, and maintenance for US (FDA) and EU (EMA, national agencies) markets.

•Prepare, review, compile, and submit regulatory dossiers including NDAs, ANDAs, 505(b)(2), MAAs, variations, renewals, labeling, Module 1-5 submissions, responses to queries from regulatory agencies.

•Oversee life‐cycle management activities: label changes, post‐approval variations, renewals, safety updates, pharmacovigilance liaison (if applicable).

•Ensure compliance with regulatory guidelines including ICH, FDA, EMA, EU GMP, as well as US and EU labeling, safety, and efficacy standards.

•Maintain and update regulatory trackers, databases, dashboards; monitor regulatory intelligence for changes in guidelines/regulations in US/EU and assess impact.

•Interact with global cross‐functional teams (R&D, QA, Manufacturing/CMC, Clinical, Safety/PV) to ensure alignment of product development and regulatory requirements.

•Liaise with external regulators and agencies; prepare for meetings, address deficiency letters, provide expert regulatory input in project teams.

•Support packaging / artwork / label review to ensure compliance with regulatory requirements for US and EU markets.

•Mentor/junior regulatory staff, provide training in regulatory processes, guidelines, and best practices.

Required Qualifications

•Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or related scientific field. A Master’s or higher is preferred.

•Minimum 8-10 years of regulatory affairs experience, with substantial exposure to the US and EU regulatory environments.

•Hands‐on experience in preparing and submitting dossiers for US (FDA) and EU (EMA or national authorities), understanding of ANDA, NDA, MAA, generics/or innovative products.

•Strong knowledge of ICH guidelines, FDA regulations, EU directives, GMP, labeling requirements, safety updates.

•Experience in life cycle management of products: variations, renewals, post‐approval changes.

•Excellent written and spoken English; strong documentation skills.

•Proven ability to work in cross‐functional, global teams.

•Strong project management skills, ability to prioritize, meet deadlines, and work under pressure.

•Attention to detail, analytical, problem‐solving mindset.

Desired / Plus

•Regulatory affairs certification (e.g. RAC) or similar.

•Experience with biologics / complex injectables / specialty pharmaceuticals.

•Familiarity with eCTD submission tools and electronic regulatory submission systems.

•Prior experience in managing labeling / artwork compliance in both US and EU markets.

•Experience dealing with pharmacovigilance, safety updates (for EU: PSUR, PADER, etc.).

Reporting Structure

•Reports to: Director of Regulatory Affairs.

•Works closely with: R&D, QA, CMC/Manufacturing, Clinical, PV, Quality Control, etc.

What We Offer

•Opportunity to work with a global regulatory consulting leader.

•Competitive compensation and benefits package.

•Career advancement through exposure to diverse projects across US/EU markets.

•Learning & development opportunities with industry experts.

•Collaborative, knowledge-driven work environment.