Biotech - Assistant Manager - Regulatory Affairs

Objective

The Assistant Manager - Regulatory Affairs will lead the preparation, review, and maintenance of regulatory documentation in compliance with EU MDR, US FDA, and ISO standards. The role ensures regulatory readiness, supports global product registrations, manages post-market surveillance (PMS) activities, and drives audit preparedness across business units.

Key Documentation & Compliance

• Prepare, update, and maintain Technical Master Files (TMFs) for all product categories.
• Conduct regular TMF reviews to ensure accuracy and compliance with global standards.
• Prepare and review technical documents such as Risk Management Reports, Preclinical Evaluations, Biological Evaluations, and Evaluation Summary Reports (ESRs).
• Manage Post-Market Surveillance (PMS) activities, integrating data from sources like MAUDE and other country-specific databases.

Regulatory Submissions & Product Registrations

Audit & Quality Readiness

Desired Candidate Graduate / Postgraduate in Regulatory affairs, Life Sciences, or related field.

Experience : 6-9 years of experience in Regulatory Affairs within Pharma, Biotech, or Medical Strong understanding of international regulatory frameworks (EU MDR, US FDA, ISO).

(ref : iimjobs.com)