Careers

Current available positions:


Flavine North America:
Flavine Europe:

Associate Director - Regulatory Affairs (based in China)

As a core support function to our European office, we are looking for applicants who would be based in China and will play a major role in assisting with regulatory compliance for Europe.

We represent more than 20 manufacturers holding DMFs and CEPs. Our development and regulatory personnel coordinate and manage product development and regulatory documentation projects to ensure approvals by the EDQM, and other EU health authorities. The Flavine Shanghai office was established in 2004 and has been instrumental in serving the need of API manufacturers in China with GMP/Regulatory support and international marketing/sales.

We are looking for highly motivated, intelligent, and honest individual to join our Shanghai team as an essential counterpart for our European office, and to work closely with our European team and monitor projects for the EU market.

Position available:

Associate Director - Regulatory Affairs

Major responsibilities:

  • Provide guidance and support to ensure Flavine suppliers are in continues state of EU GMP compliance.
  • Conduct audit as per EU GMP and regulatory assessment as per EDQM requirements.
  • Evaluate potential suppliers for their quality systems and compliance with appropiate regulatory requirements.
  • Identify deficiencies and create overall plan to assist suppliers achieve EU GMP compliance.
  • Coordinate and participate in supplier audit by customers and pre-approval inspection by regulatory authorities.
  • Provide DMF/CTD document support.
  • Provide consulting service on general EU GMP topics.

Basic responsibilities:

  • At least university degree in chemistry or pharmacy or a comparable qualificiation.
  • Minimum 5 years direct experience in pharmaceutical QA/regulatory.
  • Familiar with EU GMP requirements.
  • Minimum 3 years audit experience, mainly as lead auditor.
  • GMP professional English (oral and written)
  • Self-starter, team player with good communication skill.
  • Ability tor travel extensively.

Please send your application to hr@flavine.de

 

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