Assistant Manager Regulatory affairs

4 weeks ago

Vadodara, 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. 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 - 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). - Ensure timely preparation and updates of Post-Market Surveillance (PMS) reports, incorporating relevant findings. - Perform periodic searches of MAUDE and other relevant country-specific databases; summarize and integrate findings into PMS and Risk Management documentation. - Support audit preparations by ensuring completeness, accuracy, and readiness of technical files. - 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. Functional Skills Required - 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. - Ability to prepare audit-ready documentation. Behavioral Skills Required - Strong attention to detail with high accuracy. - Effective communication and collaboration skills for cross-functional teamwork. - Ability to prioritize tasks and manage timelines under pressure. - Proactive problem-solving and decision-making skills. - Accountability and ownership of assigned deliverables. Team Size to be Handled: Individual Contributor role, reporting to the Sr. Manager – RA. Important Links: Website: https://biotechhealthcare.com/ LinkedIn: https://www.linkedin.com/company/biotechhealthcare/ Instagram: Biotech Vision Care 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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