Sr.Executive /Assistant Manager - Regulatory Affairs -API

5 - 10 years

6.0 - 9.0 Lacs P.A.

Hyderabad

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Research And Developmentcritical process parametresimpuritiesIDENTIFICATION OF IMPURITIESVendor QualificationGTI

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities Manage regulatory affairs for API products, ensuring compliance with global regulations. Conduct vendor qualifications and manage impurity testing to ensure product quality. Develop and maintain documentation related to regulatory submissions, including CTDs and eCTDs. Collaborate with cross-functional teams to identify critical process parameters (CPPs) and implement changes as needed. Ensure timely submission of dossiers to regulatory authorities.

Pharmaceutical Manufacturing
Hyderabad Telangana +2

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