Biocon | Formulation Regulatory Affairs
2 days ago
Role - Formulation Regulatory Affairs Role - US / Canada Market
Level - Assistant Manager / Deputy Manager /Associate Manager - US Market
Required Education/Exp:
Experience Req.: 7 - 12 yrs.
Qualification: - M. Pharma / M.Sc.
Responsibilities
- Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.
- Experience and knowledge on life cycle management for the products filed in US market.
- Comprehensive and up-to-date knowledge on regulatory guidelines/requirements.
- Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing.
- Responsible to understand the requirements related to US regulatory submissions.
- Maintaining the necessary regulatory databases concurrently as on when regulatory updates are received.
- Publishing the necessary regulatory dossiers into eCTD format as per the country requirement.
- Review of technical (developmental and plant) documentations required for dossier submission.
Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.com
Required skills :-
- Hands on ANDA/ANDS Filing expertise
- A stable candidate from Pharma company
- Should have exp of US Submissions
- Well versed with regulatory guidelines.
Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.com
Kindly mention below details while sharing CV :
- Total Exp?
- Current CTC?
- Total number of ANDA/ANDS filings?
- Handling Pre-approval activities or not?
- Notice Period
- Ok for working in Bangalore? (5 Days working)
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