Assistant / Manager - Regulatory Affairs

Job Description for Assistant Manager / Manager RA

Job Profile :

• Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
• Implementing, guiding, supporting, reviewing and finally approving the dossiers and implementing the other defined activities of the department.
• Technical documents like Raw Material and finished products specification, manufacturing process, Product development report, stability reports, process validations preparation & review.
• Analytical method validation review as per the ICH guideline.
• Drug Master File review.
• Technical query response to the various regulatory authorities.
• Check artwork as per country requirements for registration and for commercial.
• Responsible for Post approval after registration for countries.
• Check PD (Product description) after product registration.
• Check final COA before commercial
• Guiding the team for FDCA applications and keeping a track of their timely renewals.

Dosage All Dosages Forms i.e., Tablet, Soft Gelatin Capsule, Hard Gelatin Capsule, Liquid Injection, Dry Powder Injection, Lyophilized Injection, Power Sachet, Syrup, Suspension, Cream, Gel & Ointment etc.

Market ROW, LATAM, African Countries