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Regulatory Affairs Associate

Chemill Pharma Limited

  • Company Industries:Medical/Pharmaceutical

Job Information

  • Post Date:2020-03-30
  • 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

Job Responsibilities:

  • Ensure timely and complete Drug Regulatory submissions
  • Coordinate and implement the registration process for the company products, with a view to continuously improvise and minimize deficiencies.
  • Compilation and submission of Documents for Tender submissions
  • Act as a bridge between the inter company departments, vendors and the Regulatory Manager
  • Personally write and review regulatory submissions as needed
  • Organize electronic database (electronic library) of Regulatory Documents & offline Library
  • Consistently support Regulatory Affairs Manager to evaluate & optimize Registration process, based on any deficiencies received
  • Consistently support Regulatory Affairs manager to evaluate & optimize Registration process, based on any deficiencies received
  • Consistently improve regulatory skills in local office or regional and at our manufacturers, where applicable
  • Successfully negotiate with local authorities and vendors on behalf of Company objectives
  • Be very rigorous about Filing Systems and Document Management Systems
  • Consistently fulfill the mission of the company

Requirements:

  • Degree in Science, Engineering or any other related disciplines
  • At least 2 years of regulatory working experience, preferably in medical device or pharmaceutical industry in Hong Kong
  • Experience in negotiating with regulatory authorities would be an advantage.
  • Existing network of connections in local industry and statutory bodies would be an advantage.
  • Excellent organizational and interpersonal skills, positive working attitude and be a good team player.
  • Attend to details and able to work with limit supervision.
  • Able to work with both internal and external customers from different level.
  • Excellent interpersonal and communication skills.
  • With fluency in both spoken and written English and Chinese (Mandarin)

 

We offer attractive remuneration and fringe benefits. For interested parties, please send your full CV with your availability, current and expect salary by "Clicking Apply Now"

Personal data will be used for recruitment purpose only.

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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