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Drug Safety Associate

Senior Drug Safety Associate

Drug Safety Associate 2

About the job Position: Regulatory Affairs Manager Location: Hyderabad Qualification: B.Pharm / M.Pharm/ Pharm.D Experience: 8 to 10 + Years Shift: 2pm-11pm IST Job Responsibilities: We are seeking an experienced Regulatory Affairs Manager with a strong background in ANDA submissions and US FDA compliance. The ideal candidate will lead the preparation and management of regulatory filings, particularly ANDAs and post-approval submissions, while working cross-functionally to ensure timely and compliant product approvals. The role also involves mentoring junior staff, driving regulatory intelligence initiatives, and supporting strategic client interactions. Key Responsibilities: - Manage the end-to-end preparation and submission of Abbreviated New Drug Applications (ANDAs) and related post-approval submissions including Annual Reports, Complete Response Letters (CRLs), and Information Requests (IRs). - Coordinate with cross-functional teams (R&D, Quality, Manufacturing, Packaging, Marketing) to collect required data and documentation for timely regulatory submissions. - Review and compile CMC documentation in compliance with FDA guidelines; ensure manufacturing and control processes meet regulatory expectations. - Lead and mentor junior regulatory team members, ensuring best practices and knowledge transfer. - Identify regulatory risks early and implement mitigation strategies across multiple product portfolios. - Collaborate with internal stakeholders to maintain regulatory compliance throughout product lifecycle, including change control management. - Implement and manage regulatory change control processes; assess the impact of technical, formulation, or packaging changes on product registration status. - Maintain up-to-date knowledge of US FDA regulations, GDUFA, MAPPs, ICH guidelines, and other relevant regulatory frameworks. - Provide regulatory input during promotional material reviews to ensure compliance with FDA's OPDP and advertising regulations. - Support regulatory filings and life cycle maintenance for products in semi-regulated and ROW (Rest of World) markets. - Address client inquiries related to regulatory processes, submission strategies, and compliance requirements. - Assist in identifying potential clients and contribute to business development efforts, including proposal and strategy development for regulatory services. Qualifications & Skills: - Master's degree in Pharmacy, Chemistry, Life Sciences, or related field. - Experience: 8 to 10 + Years of hands-on experience in US FDA regulatory submissions, especially ANDA dossier compilation and lifecycle management. - Strong understanding of eCTD structure, FDA portals (ESG, CDER NextGen), SPL submissions, and labeling requirements. - Proven experience in change control assessment, regulatory impact analysis, and risk-based submission planning. - Excellent communication skills, with the ability to liaise with internal teams and external stakeholders. - Strong leadership and team mentoring capabilities. - Working knowledge of regulatory pathways in semi-regulated and ROW markets is a plus. Preferred Tools/Systems: FDA ESG, CDER NextGen Portal Pharmaready, Veeva Vault, Extedo eCTD Manager (or similar EDMS/eCTD tools) Regulatory Intelligence platforms (e.g., Cortellis, Elsevier PharmaPendium)

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Vigilare - Regulatory Affairs Manager 

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Apply to 1 Vigilare Biopharma jobs on iimjobs.com, India's No.1 Management job portal. Explore Management job in Vigilare Biopharma Now! Comapny page, IIM MBA Jobs, Ecommerce, Retail, Business, Development, Manager, Technology, Healthcare, Telecom, Insurance, FMCG, Media, BFSI, Director, VP/AVP, CEO/CFO, AGM/DGM

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