Sr Executive - Regulatory Affairs
Sr Executive - Regulatory Affairs
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Job Description
About the JobSkillsKnowledge of regulatory requirementsFDAAttention to detailStrong communication skillsProject managementAbility to work under pressureResearch skills
We are hiring forSr. 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
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Remote Work :
No
Employment Type
Full Time
