Manager – Regulatory Affairs (CRLB) – Mumbai
Location: Mumbai, India
Category: Regulatory Affairs
Platform: ThePharmaDaily.com Global Job Portal
Role Overview
This position is designed for a senior-level Regulatory Affairs professional with extensive expertise in managing complex regulatory projects. The Manager will act as a specialist individual contributor with deep functional knowledge, capable of developing advanced regulatory solutions and leading high-impact initiatives across the product lifecycle.
Key Responsibilities
Lead the development, review and submission of product registration dossiers, progress reports, supplements, amendments and periodic safety/experience reports.
Liaise directly with regulatory authorities to support and expedite registration approvals.
Serve as the primary regulatory contact throughout the lifecycle of assigned products.
Contribute to product planning, regulatory strategy, risk management and Chemistry, Manufacturing and Controls (CMC) activities.
Ensure timely approval of new products including pharmaceuticals, biologics or medical devices, and maintain compliance for marketed products.
Represent Regulatory Affairs in cross-functional interactions with marketing, R&D and external regulatory bodies.
Provide strategic regulatory guidance on manufacturing changes, line extensions, labeling requirements, and regulatory interpretations.
Required Qualifications
Education:
Associate Degree or higher in a relevant scientific or regulatory discipline.
Experience:
Minimum 7 years of progressive experience in Regulatory Affairs within the pharmaceutical, biotechnology or medical device industry.
Demonstrated expertise in managing complex submissions and interacting with regulatory authorities.
Why This Role Is Important
This position is ideal for professionals seeking a high-impact role within a globally connected environment. The role demands strong regulatory acumen, strategic thinking and the ability to develop compliant, market-ready solutions within a competitive and evolving regulatory landscape.
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