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