Formulation Regulatory Affairs

1 month ago


bangalore, India Biocon Full time

Role - Formulation Regulatory Affairs Role - US / Canada Market

Level - Associate Manager / Manager - US Market


Required Education/Exp:

Experience Req.: 10 - 16 yrs.

Qualification: - M.Sc. / M. Pharma.


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 :-


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 :-


Kindly mention below details while sharing CV :

  • Total Exp
  • Current CTC
  • Total number of ANDA/ANDS filings,
  • Notice Period
  • Ok for Bangalore onsite job. (5 Days working)


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