Company: Torque Pharmaceuticals Position: Executive – Regulatory Affairs Department: Regulatory Affairs Location: Mohali Qualification: B. Pharm / M. Pharm Experience: 2–5 Years
Torque Pharmaceuticals is inviting applications from experienced pharmaceutical professionals for the position of Executive – Regulatory Affairs at its Mohali location. The role involves preparation and management of regulatory documentation for international markets and coordination with cross-functional teams to ensure timely and compliant regulatory submissions.
Key Responsibilities
Compile and prepare regulatory dossiers in CTD, ACTD and eCTD formats for ROW markets, including ASEAN, GCC, Africa and other regions.
Review product development, technology transfer, validation, specifications, manufacturing, stability and labeling documents for accuracy and regulatory compliance.
Prepare regulatory dossiers and coordinate responses to regulatory authority queries within stipulated timelines.
Ensure completeness, adequacy and accuracy of regulatory data submitted to health authorities.
Coordinate with internal departments for compilation and review of quality and regulatory documents.
Support post-approval changes and review product artworks, SmPCs and leaflets.
Track and maintain country-wise and product-wise registrations, renewals and regulatory commitments to ensure timely compliance.