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Regulatory Affairs Assistant Manager
4 months ago
Regulatory Affairs Associate Manager
- Position Title: Regulatory Affairs Assistant Manager - APAC
- Work area: APAC - Regulatory Affairs
- Reports To: Head, APAC - Global Regulatory Affairs
- Location: Singapore/Thailand/Taiwan/Hong Kong
- Job Responsibilities:
- Support the regulatory management of Unilever H&W Vitamin, Mineral & Supplement (VMS) products in Asia Pacific Regions.
- Establish and implement regional regulatory/safety guideline with other regional and country regulatory team.
- Responsible, together with oversea regulatory teams, to undertake a range of functions (including but not limited to):
- Develop and maintain product regulatory dossiers
- Conduct regulatory reviews of product formulations for compliance against various regulations, relevant codes of practice and market requirements
- Create and ensure accuracy of product labelling template
- Review and approve product labelling for regulatory compliance
- Manage regional regulatory strategies to smooth products market access compliance
- Review and approve marketing materials for regulatory compliance
- Contribute to the development, implementation and maintenance of regulatory SOPs, procedures and data management to ensure due diligence and sponsor obligations are met
- Support Post marketing surveillance and AE reporting/analysis per regulation
- Review safety data and perform safety assessment as required per regional regulation.
- Collaborate with internal departments regionally to facilitate product development and sales.
- Ensure regional regulatory compliance in liaison with local regulations and internal corporate standards and policies, regional procedures and cross functionals team as required.
- Prepare and implement the annual regional registration/notification plan according to business objectives and dossier readiness.
- Be in direct contact with the regional Health Authorities.
- Conduct regulatory activities as required.
Job Requirements:
- Bachelor’s/Master’s Degree in health-related science, life science; Pharmacy or Medical degree desirable.
- Solid experience in similar field/job function for 5+ years in multinational companies.
- China Cross Boarder E-Commerce experience will be an advantage
- Proactive, self-motivated and well-organized
- Be able to work independently as well as being a team player.
- Multitasking and problem solving attitudes with strong attention to details.
- Strong influencing skills, previous experience of influencing Ministry of Health is desirable.
- Basic understanding of technical regulation (testing and specification) and GMP, GVP & GCP is required.
- Excellent communication, interpersonal and presentation skills, both in spoken and written English and Mandarin. Other language skill will be an advantage.
- Strong professional integrity
- Ability to assess and provide risk assessment/mitigation plans based on regulations and ability to communicate to the business.
- Ability to prioritize and organize in an ever-changing environment whilst under pressure
