WE ARE HIRING SENIOR EXECUTIVE REGULATORY AFFAIRS (EUROPE MARKET)

Location: Mumbai - Malad

Industry: Pharmaceutical Formulations

Experience: 6-8 Years

Qualification: B.Pharm / M.Pharm / M.Sc. or equivalent

We are looking for a Senior Executive Regulatory Affairs with strong experience in the European pharmaceutical market to support regulatory submissions and product registrations for pharmaceutical formulations.

Key Responsibilities

- Prepare, compile and review regulatory dossiers for European markets.
- Support preparation and submission of CTD / eCTD dossiers for generic pharmaceutical products.
- Handle regulatory activities related to MAA, variations, renewals and lifecycle management.
- Coordinate with Formulation R&D;, Analytical R&D;, QA, QC, CMC and Manufacturing teams for dossier preparation.
- Review technical documents, specifications, analytical data, stability data and formulation development information.
- Support responses to regulatory authority queries and deficiency letters.
- Maintain regulatory submission trackers and ensure timely submission of required documents.




- Monitor regulatory guidelines and changes applicable to EU pharmaceutical registrations.
- Support preparation and maintenance of Module 1, Module 2 and relevant Module 3 documentation.
- Coordinate with external consultants, regulatory partners and European customers/partners as required.
- Maintain accurate regulatory records and ensure compliance with applicable EU regulatory requirements.

Desired Candidate Profile

- 6-8 years of experience in Regulatory Affairs Europe Market.
- Strong exposure to EU pharmaceutical regulations and submissions
- Experience with CTD/eCTD dossier preparation and review.
- Knowledge of EU variations, renewals and lifecycle management
- Experience in generic pharmaceutical formulations preferred
- Positive understanding of ICH guidelines and EU regulatory requirements.
- Strong documentation, coordination and communication skills
- Experience with regulated markets will be an added advantage

Interested candidate can mail their cv on [email protected] or WhatsApp on (phone hidden).

📌 Senior Regulatory Affairs Executive - Europe Market (Mumbai)
🏢 Archerchem Healthcare
📍 Mumbai