Postgraduate Assistant Manager

6 days ago

Ahmedabad, India Biotech Healthcare Full time

Role Objective Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements. This position requires close collaboration with internal stakeholders to ensure consistent regulatory compliance across the organization. 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., Demonstrated experience in dossier preparation, technical file management, and compliance documentation. ~ Proficiency in MS Office and regulatory database searches. Prepare and maintain Technical Master Files (TMFs) for all products, ensuring timely updates and regulatory accuracy. # Conduct scheduled reviews of TMFs to ensure consistency and alignment of technical content across product categories. # Prepare and update critical technical documents, including Risk Management Reports, Preclinical and Biological Evaluations, and Evaluation Summary Reports (ESRs). # Perform periodic searches of MAUDE and other relevant country-specific databases; summarize and integrate findings into PMS and Risk Management documentation. # Review, compile, and finalize product registration dossiers in line with country-specific regulatory requirements. # Collaborate with the Regulatory Affairs team to monitor compliance activities, track file status, and provide daily progress updates. # Provide regulatory and documentation support to cross-functional teams in line with organizational priorities. In-depth knowledge of regulatory requirements and submission processes across multiple markets. Expertise in the preparation of dossiers, TMFs, PMS, and Risk Management documentation. Strong documentation, review, and editing skills. Familiarity with regulatory intelligence tools and database search methodologies. Website: LinkedIn: Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

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