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Regulatory Affairs Manager

Reports to: Global Regulatory Affairs Manager

Based in: Beijing

Job Purpose Summary

Product registrations and renewals for East Asian (EA) Region. Primary focus on China.

Key Responsibilities:

  • Regular contacts with Regulatory Authorities and regulatory consultants for the follow-up of dossiers, documentation or queries, related to veterinary topical products and hard surface detergents/disinfectants.
  • Follow up on legislation and regulations within all EA countries.
  • Review and approve product labelling, new and at every update.
  • Review/ approve production documentation, i.e. formula, raw material monographs, test methods, etc. particularly pertaining to product registration dossiers.
  • Review clinical trial protocol and final reports.
  • Technical writer in other regulatory compliance documents.
  • Research of chemical compounds for R&D project development.
  • Support the R&D team providing information on new guidelines and on new raw materials allowance in EA countries.
  • Participate in project teams.
  • Participation in professional and scientific organizations, industry conferences, and training.
  • Assist with review of departmental invoices and payment requests.
  • Occasional national and international travel assignments.
  • Previous registration experience and knowledge of national and international GMP/GLP Guidelines is preferred.
  • Previous experience and knowledge of requirements for products registrations in designated countries (hygiene, feed additive and veterinary products).
  • Other duties as assigned.

Required Skills:

  • Minimal University Degree in Chemistry, Biochemistry, Microbiology, Veterinary sciences or equivalent.
  • Min. of 2 years of experience in Regulatory Affairs (registrations).
  • Knowledge of international regulatory requirements for detergents, sanitizers, veterinary drugs and feed additives. Knowledge of dairy production, in-vitro testing and clinical trials is an asset.
  • Languages (spoken and written): English, Chinese.
  • Very good communication skills (verbal/written) and computer literate.
  • Able to handle multiple projects simultaneously

On the subject of us

At Asian Agribusiness Consulting our mission is the promotion and development of agribusiness across Asia. We provide specialist research and consulting services for our clients who have intentions of ratcheting up their presence in Asia be they start-ups companies to blue-chip companies.

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