Senior Regulatory Affairs Executive - Europe Market

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
• Good 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 removed] or WhatsApp on [phone removed].