Sr. Executive
3 weeks ago
Job Title: Sr. Executive - Regulatory Affairs
Job Location: Ahmedabad, 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.
Thanks & Regards,
Yesha (HR)
Mo- 98751 70543
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https://lifelancer.com/jobs/view/922ef7162212cb2aa47f851309c51db2
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