Regulatory Affairs Specialist

3 weeks ago


Bangalore, India Biocon Full time

Role - Formulation Regulatory Affairs Role - US / Canada Market

Level - Deputy Manager /Associate Manager/ Manager - US Market

Required Education/Ex p:

Experience Req.: 9 - 14 yrs.

Qualification: - M. Pharma / M. Sc.

Responsibiliti es:

  • 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 submis sion.

Required sk ills :-

  • Hands on ANDA/ANDS Filing expertise.
  • A stable candidate from Pharma company.
  • Should have exp of US Submissions.
  • Well versed with regulatory gui delines.

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?
  • Handling Pre-approval activities or not?
  • Notice Period?
  • Ready to work in Bangalore (onsite) ? (5 Days working)

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