04/05 Siva
HR at BVR People Consulting

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DGM/AGM/Senior Manager/Head - Regulatory Affairs - US Injectables (15-20 yrs)

Bangalore Job Code: 3271

Job Description :

We are currently looking for Head - Regulatory Affairs who is expert in handling US market ANDA filling & Post approval for Injectable products for our Pharmaceutical Client.

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

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