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