Job Responsibilities:
Report to APAC Regulatory Affairs Head.
Support the regulatory management of Unilever WBC 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 overseas 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 functional teams as required.
Prepare and implement the annual regional registration/notification plan according to business objectives and dossier readiness.
Be the regulatory subject matter expertise to provide advice and risk assessment/mitigation plans for Unilever WBC businesses.
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.
Consumer VMS products experience is preferred, candidate without such relevant experience will be less considered.
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
