- Lead H&W China Regulatory Affairs team and be responsible for team capability & capacity development.
- Establish and implement national regulatory guideline with other regional and country regulatory team.
- Work cross-functionally with internal stakeholders at global and local level to ensure business objectives are met through strong regulatory strategy and partnership.
- Pro-actively lead the review, impact-assessment and implementation of all applicable regulations and legal requirements (CBEC, domestic market and exportation) operating as a key internal subject matter expert.
- Ensure relevant regulatory risk assessments are communicated to relevant functional experts to inform strategy on ingredients, formulations, and any advertising, brand promotion and communication.
- Lead regulatory landscape overview and regulatory management of VMS products & Innovation; includes but not limits:Formulation, ingredients, raw materials, product specifications and claims review,Review and approve packaging and marketing materials to comply with local regulations,Ensure labelling requirements meet local regulation,Lead product notification/ registration (includes technical dossier preparation),Support in stability and shelf-life considerations,
- Liaise with internal/external stakeholders and authorities' officers to ensure quick and quality submission dossier for notification and registration.
- Lead the reviewing and interpretation of local new and proposed rules, regulations and enforcement activities impacting the use of ingredients, safety, labeling and advertising, which may have significant impact on planned business actions and/ or proposals. Direct the activities of external regulatory consultants who may be required as subject matter experts on specific key programs or activities.
- Ensure local regulatory compliance (product license renewal, etc...) in liaison with local regulations and corporate policies, global & local procedures and multifunction team as directed.
- Answer enquiries and provide best in class solution as required.
- Be in direct contact with the local Health Authorities and trade associations.
- 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.
- Conduct regulatory activities as requested, based on business needs.
- 10+ years of experience in the field of VMS/ consumer healthcare products in China CBEC/Domestic markets including cross-functional interactions, technical leadership is essential.
- Bachelor/Master degree holder in health-related science, Life Science, Regulatory Science, Food Science and Technology; Pharmacy or Medical degree desirable.
- Knowledge of China regulations and VMS requirements as well as strong understanding of technical regulation (testing and specification) and GMP, GCP, HACCP are required.
- Ability to assess regulatory risks and opportunities, and the impact these may have on the existing and innovation portfolio.
- Thorough understanding of workflow management, project management, multitasking and managing shifting priorities is required.
- Knowledge across a wide range of product categories (food/ food supplements/Specialized food/herbal product/OTC/medicines) including manufacturing and technical systems is required.
- Ability to identify process improvement opportunities to achieve improved, more consistent results and shorter development times is required.
- Strong professional integrity & influencing skills, previous experience of regulatory advocacy is desirable.
- R&D knowledge would be desirable, as well experience in Project Management and Digital Tools.
- Proven facilitation skills, with multitasking and problem-solving attitude.
- Excellent communication, presentation, and organizational skills, in both spoken and written English & Mandarin.
- Strong Team mindset. Ability to collaborate with multiple stakeholders both internally and externally at global & local level.
- Self-motivated & self-starter, proactive and with a high level of initiative and persistence, with a hands-on approach and result-oriented mindset.
- Enterpreneurial approach and business acumen is required, with a track record of providing solutions and thinking out of the box.
- Strong execution capabilities with ability to handle multiple assignments and manage major projects to successful completion.
- Team leadership: experience in a combined global and local team dynamic across all functions.
- You are energized by delivering fantastic results. You are an example to others – both your results and your resilience. You are constantly on the lookout for better ways to do things, engaging and collaborating with others along the way.
- As an individual you are the one responsible for your own wellbeing and delivering high standards of work. You must also focus on the Consumer and what they need. You are humble and have your head up, looking around to interpret evidence and data smartly, spot issues and opportunities to make things better.
- PASSION FOR HIGH PERFORMANCE : Takes personal responsibility and accountability for execution and results. Has an owner's mindset, using data and insight to make decisions.
- PERSONAL MASTERY : Sets high standards for themselves. Actively builds own wellbeing and resilience.
- TEAM PLAYER : Collaborates with multifunction and leads on RA projects.
- CONSUMER LOVE : Whatever their role, always looks for better ways to serve consumers. Invests time inside and outside to understand the needs of consumers.
- PURPOSE & SERVICE : Has humility, understanding that leadership is service to others, inside and outside Unilever.
- AGILITY : Explores the world around them, continually learning and developing their skills.
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H&W Regulatory Affairs Manager - Shanghai, 中国 - Unilever
描述
Description
:The successful candidate will co-ordinate the know-how and roll-out of VMS products in China. Working together with internal or external stakeholders, the candidate will be responsible for the following activities.
Driving detailed business understanding on the different product notification/registration requirements for VMS in China (and international markets outside China as desirable but not mandatory). Specifically, the candidate will be responsible for:
Key Skills, Attributes and Experience
Leadership
Critical SOL (Standards of Leadership) Behaviors
Unilever embraces diversity and encourages applicants from all walks of life This means giving full and fair consideration to all applicants and continuing development of all employees regardless of age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage and civil partnership, and pregnancy and maternity.
Work Location: China Shanghai Headquarter – U66
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