Hiring For AM/ Manager - Regulatory Affairs at Thane, Mumbai

8 - 10 years

7.0 - 10.0 Lacs P.A.

Thane

Posted:2 months ago| Platform: Naukri logo

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Skills Required

USFDARegulatory AffairsDrug Regulatory AffairsRA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Coordinate, compile regulatory documentation of filing activities/post approval changes for submission to regulatory authorities Approval with all relevant regulators USFDA Formulate RA standards, policies to ensure that regulatory compliance Required Candidate profile Must be from Life Sciences, have experience with USFDA, Compliance, ISO 13485, basic requirements of EU guidelines, medical device related regulations its requirements for approval, change management

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