Skills:
Knowledge of regulatory requirements, Attention to detail, Strong communication skills, Project management, Ability to work under pressure, Research skills, FDA,

We are hiring for Sr. Executive - Regulatory Affairs.

Qualification: B.pharm/M.pharm

Experience - 2 to 5 years only

Location - Sola, Ahmedabad

Work mode - on site

Role & responsibilities:-

• Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
• 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.
  
  

Market ROW: Africa, Latin America, Eastern Europe, the Middle East, and parts of Asia country exposure is required.

Thanks & Regards,

Yesha (HR)

Mo- 98751 70543