Executive - Regulatory Affairs

Position: Executive

Experience Required: 3 to 8 years
Qualification: M.Pharm / M.Sc.

Must Have Experience: Dossier Preparation, Hands-on experience of at least 3 modules, eCTD compilation.

Profile & Exposure :
For EU Market - Pre and Post Approval

• Formulation Regulatory experience of various dosage form like Solid oral / Topical / Solutions /Suspension.
• EU dossier compilation especially for Module 1, 2 & 3
• Seasoned experience in handling of various EU procedure like DCP, MRP, National
• National phase handling for EU procedures.
• Post approval variation compilation and filling to various EU agencies