Formulation Regulatory Affairs

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)