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Inviting candidates for Sr. Specialist - Regulatory Affairs

Responsibilities:-

• Responsible for leading and executing CMC regulatory strategies for assigned post‑approval pharmaceutical products in alignment with global regulations, guidance and defined regulatory strategies, including preparation and critical review of data and documents required for post‑approval CMC submissions and lifecycle management.
• Accountable for authoring, reviewing, and coordinating CMC documentation to support worldwide post‑approval changes and lifecycle activities (variations, supplements, amendments) for commercial products, under the strategic direction of senior regulatory CMC scientists or product leads.
• Experienced in evaluating scientific and technical information to assess the merits and regulatory impact of proposed post‑approval changes, ensuring that rationales are clearly artic

📌 Sr. Specialist (Mumbai)
🏢 Genpact
📍 Mumbai