GM Regulatory Affaire Row/ EU Market For Pharma Nagpur plant OSD

4 weeks ago

Nagpur, India Select Source International Full time

Job Summary:

We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets.

Key Responsibilities

Regulatory Strategy & Compliance:
• Coordinate with agents, partners, and MOHs to define submission strategies.
• Prepare internal strategy documents and lead regulatory discussions for new products.

Dossier Management & Submissions:
• Manage CTD/ACTD/eCTD submissions for new registrations, renewals, and variations.
• Ensure dossiers and query responses are complete and compliant.
• Coordinate with plants for registration samples and related documentation.

Stakeholder Collaboration:
• Work with internal teams and external partners to gather and finalize technical documents.

Regulatory Operations Oversight:
• Compile and submit responses to MOH/partner queries on time.
• Track regulatory submissions as per calendar.
• Oversee renewals of FDA licenses, WHO GMP, COPPs, etc.

Training & Regulatory Intelligence:
• Conduct training on updated guidelines.
• Share critical regulatory updates with teams.

Documentation & Reporting:
• Review technical and administrative dossier sections.
• Maintain monthly regulatory status reports.
• Coordinate site registrations and pre-audit activities.

Leadership & Team Development:
• Guide the RA team for efficiency and compliance.
• Promote process improvements and regulatory best practices.
• Handle additional tasks under the RA function.

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