openings For Regulatory Affairs(Formulation)- Executive / Sr executive

Role & responsibilities

Designation: Executive / Sr. Executive Regulatory Affairs (Formulation)

Experience: 2 - 8 Years

Job Location: MSN R&D Center, Pashamylaram, Hyderabad

Job Summary

MSN Laboratories is looking for an experienced Regulatory Affairs professional to support regulatory activities for pharmaceutical formulations intended for ROW (Rest of World) markets. The role involves preparation, review, compilation, and maintenance of regulatory dossiers and coordination with cross-functional teams to ensure timely and compliant submissions.

Key Responsibilities

• Prepare and review regulatory dossiers for finished pharmaceutical formulations for ROW markets.
• Compile and review CTD/eCTD and country-specific dossiers in accordance with applicable regulatory requirements.
• Review formulation, manufacturing, analytical, stability, packaging, and other CMC-related documents for regulatory submissions.
• Coordinate with Formulation R&D, Analytical R&D, QA, QC, Production, Packaging, and other cross-functional departments for dossier preparation.
• Support new product registrations, renewals, variations, amendments, and other post-approval regulatory activities.
• Research and interpret regulatory guidelines and requirements applicable to assigned ROW countries.
• Prepare responses to regulatory authority queries, deficiencies, and clarification requests.
• Coordinate with overseas regulatory agents, partners, and consultants for submissions and regulatory approvals.
• Prepare and review product information, labels, artwork, PIL/SmPC, and other country-specific regulatory documents.
• Maintain submission trackers, approval databases, regulatory commitments, and correspondence.
• Monitor regulatory submission timelines and ensure deliverables are completed within agreed timelines.
• Support regulatory strategy and provide regulatory inputs during product development and commercialization.
• Keep abreast of changes in regulatory guidelines and communicate relevant updates to internal stakeholders.

Candidate Profile

• M.Pharma/B.Pharma
• 28 years of relevant experience in Pharmaceutical Regulatory Affairs, preferably in formulation/finished dosage products.
• Experience in ROW regulatory submissions and registrations is preferred.
• Good understanding of CTD dossier requirements and CMC documentation.
• Exposure to regulatory activities such as new registrations, renewals, variations, amendments, and deficiency responses.
• Strong coordination and communication skills with the ability to work effectively with cross-functional teams.
• Good documentation skills and attention to detail.

Job Location

MSN R&D Center, Pashamylaram, Hyderabad