Job Description

Job Title: Sr. Executive - Regulatory Affairs
Job Location: Gandhinagar, Gujarat, India
Job Location Type: On-site
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
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
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