Regulatory Affairs Manager - Pharma

This is a role for an experienced Regulatory Affairs Manager with extensive experience in product registration (with CDSCO, FSSAI, etc) and in compiling dossiers, reviewing artworks and in liaising with regulatory bodies.

Responsibilities include (but are not limited to):

• Compile Dossiers (ACTD) for Product registration
• Liaise with QA, QC, R&D and Marketing teams when compiling dossiers and for product registrations
• Prepare and submit regulatory applications for new products (to CDSCO, FSSAI, etc) and changes, ensuring timely approvals and market release.
• Translate regulatory requirements into actionable submission plans and manage submission timelines.
• Provide technical guidance during strategy formulation, submission preparation, and interactions with regulatory bodies.
• Collaborate with global teams and product managers to support product changes and ensure compliance with internal policies.
• Maintain strong relationships with regulatory agencies and serve as a liaison between Regulatory Affairs and other functions.
• Review labeling, promotional materials, and product/process changes for regulatory compliance.
• Author and review standard operating procedures (SOPs), ensuring compliance with current regulatory requirements.
• Contribute to process improvements that impact Regulatory Affairs, Quality Assurance, and other departments.
• Support corporate quality assurance initiatives and monitor regulatory and quality commitments.