Regulatory Affairs Executive
4 weeks ago
Role ObjectiveKey objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.Desired Candidate Profile- Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline. - 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare. - Strong understanding of global regulatory guidelines and dossier preparation. - Detail-oriented, with excellent organizational and analytical skills. - Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems. - Good written and verbal communication skills.Roles & Responsibilities- Screen and analyze documents received for product registration requests as per country-specific guidelines. - Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements. - Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities. - Draft and coordinate responses to regulatory queries with appropriate documentation and justifications. - Arrange supportive batch-related documents (e.g., DOC, COA) for registration samples. - Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices. - Support the Compliance team by providing updated documents required for technical file preparation. - Periodically review and update Technical Master Files to ensure consistency across product categories. - Coordinate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries. - Ensure timely preparation and submission of documents related to audit findings. - Adhere to departmental priorities and provide support for additional tasks as assigned.Functional Skills Required- Knowledge of international regulatory requirements and guidelines. - Expertise in dossier compilation, review, and submission processes. - Ability to prepare and analyze technical and compliance-related documentation. - Familiarity with audit documentation and regulatory query management. - Document management and record-keeping skills.Behavioral Skills Required- Strong attention to detail and accuracy. - Ability to work effectively under pressure and meet strict deadlines. - Team player with strong collaboration and coordination skills. - Proactive, adaptable, and willing to take initiative. - Professional communication and interpersonal skills.Team Size to be Handled:Individual contributor role, reporting to the Assistant 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.
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Regulatory Affairs Specialist
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Regulatory Affairs Associate
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Regulatory Affairs Manager
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Regulatory Affairs Specialist
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Senior Manager Regulatory Affairs
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New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory Affairs Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...
