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06/04 Siva
HR at BVR People Consulting

Views:428 Applications:56 Rec. Actions:Recruiter Actions:0

Head/DGM/AGM/Senior Manager - Regulatory Affairs/QA/QC (10-20 yrs)

Tamil Nadu Job Code: 12469

JD for Regulatory Affairs :

Regulatory Head for US Market :

Role : RA Head for US market

Designation : DGM/AGM/Senior Manager

Experience : 15-20 Years in Regulatory Affairs plus QA/QC experience

Candidates preferably from Injectables / Parentrals Background

Education : Any UG /PG

Reporting : Directly to Managing Director

Job Location : Hosur Location

Roles and Responsibilities :

- Build and nurture a team for US focussed regulatory

- Manage new submissions of ANDAs

- Mentor and provide guidance to cross functional team on regulatory requirement for products

- Train the cross functional team on regulatory updates

- Act as program manager and work with customers to ensure timely and smooth filing.

- Assist the customer for product launch in the US market.

- Management of Post Approval Supplements: CBE, CBE-30, Prior Approval Supplements, Annual reports, Site Transfers etc.

- Management of Deficiencies: Telephone, Minor, Major CMC Amendments in compliance to the queries from US FDA

NOTE : If above position is suitable to you, please contact me & share your profile

Keyskills : RA QA Regulatory Affairs US Market Senior Management

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

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