Job Description
Senior Manager – Global Regulatory Affairs to lead regulatory activities for peptide and complex generic products across the United States, European Union, United Kingdom, and Emerging Markets. The role will be responsible for developing and executing global regulatory strategies, leading dossier submissions and health authority responses, supporting scientific advice and pre-submission interactions, and managing the regulatory lifecycle of products across multiple markets. The ideal candidate will bring solid experience in CTD/eCTD submissions, ANDAs, EU/UK regulatory procedures, global registrations, regulatory strategy, CMC documentation, health authority interactions, and post-approval lifecycle management. Experience with peptide products, complex injectables, or other complex generic products is highly desirable. Key Roles &

Responsibilities
1. Global Regulatory Strategy & Submissions
• Develop and execute regulatory strategies for peptide and complex generic products across the US, EU, UK, and Emerging Markets.




• Lead review and submission of regulatory dossiers in CTD, eCTD, ACTD, and country-specific formats, as applicable. • Drive regulatory planning from development through submission, approval, launch readiness, and post-approval lifecycle management.
• Assess country-specific regulatory requirements, submission pathways, documentation gaps, and potential regulatory risks.
• Ensure high-quality and timely submissions in accordance with applicable health authority
requirements and committed project timelines.
2. Cross-Functional Regulatory Leadership
• Coordinate closely with R&D;/Formulation Development, Analytical Development, QA, QC, Manufacturing, Clinical/BE, Supply Chain, Program Management, Commercial, and other stakeholders to obtain regulatory submission documentation.
• Review documents received from cross-functional teams for adequacy, completeness, scientific consistency, and regulatory compliance before incorporation into reg

📌 Senior Manager (Bengaluru)
🏢 Biocon
📍 Bengaluru