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