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Regulatory Affairs Manager

Chemill Pharma Limited

  • Company Industries:Medical/Pharmaceutical

Job Information

  • Post Date:2020-04-04
  • Career Level:Entry Level
  • Location:Not Specified
  • Yr(s) of Exp:2 years
  • Qualification:Degree
  • Salary:Salary negotiable
  • Employment Type:Full Time, Permanent
  • Job Function:Pharmaceutical

Job Description

Responsibilities:

  • Lead a team to cause large number of new product filings
  • Ensure optimum efficiency and zero deficiency new submissions to DH
  • Negotiate effectively with DH, to ensure timely approvals of new products & CORP applications
  • Provide teams with support regarding regulations and best practices
  • Support tendering teams with documents related to tender submissions
  • Support tender teams with RA related queries and requests
  • Other activities which support smooth operation and fulfillment of tender obligations
  • Define and upkeep SOP's for team to ensure consistency
  • Build and maintain updated document library (Online & Offline)
  • Manage database and reports related to RA activities
  • Upkeep of existing Drug Registration & CORP's
  • Release of Product as per Registered Particulars
  • Generate weekly reports on Regulatory Activity / Progress and Quarterly / Annual Reports
  • Successfully complete projects assigned
  • Maintain and Empowering context for tasks & jobs being handled
  • Consistently improvise performance of the entire process and team

Requirements:

  • Degree in Science
  • Minimum 5 years of regulatory working experience of leading a team
  • Rapport with HA / DH
  • Good track record of filings / approvals

We offer attractive remuneration and fringe benefits. Interested parties, please send your full CV stating the position, your availability, current and expected salary via email by clicking "Apply Now".

Company Info

Chemill Pharma is part of a large Pharmaceutical Group having over 20 years of experience in the global pharmaceutical market.  Established in 1999 in Hong Kong, we support generic drug companies, to produce and launch products successfully.  We are now expanding our business to support the strategic growth of the business, we have exciting opportunities for talented, motivated and high caliber individuals to join us as one of our professional associates.

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