Assistant Manager Regulatory affairs

Role Objective

Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements. The role ensures timely preparation and updating of Technical Master Files, supports product registrations, manages post-market surveillance activities, and contributes to audit readiness. This position requires close collaboration with internal stakeholders to ensure consistent regulatory compliance across the organization.

Desired Candidate Profile

• Graduate / Postgraduate in Pharmacy, Biotechnology, Life Sciences, or a related discipline.
• 6–9 years of experience in Regulatory Affairs, preferably in the pharmaceutical, biotechnology, or medical devices industry.
• Strong understanding of international regulatory guidelines (e.g., EU MDR, US FDA, ISO standards).
• Demonstrated experience in dossier preparation, technical file management, and compliance documentation.
• Proficiency in MS Office and regulatory database searches.

Role & Responsibilities

Functional Skills Required

Behavioral Skills Required

Team Size to be Handled :

Individual Contributor role, reporting to the Sr. Manager – RA.

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Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.