Assistant Manager - Regulatory

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