RA-Registration Assistant Manager
Salary CNY250000 - CNY300000 per annum
Consultant Lavency Zhu
Date posted 22 March 2018No.1539 West Nanjing Road Shanghai 200040 Robert Walters China
The assistant registration manager will be responsible for the design and deployment of application work plan and ensure the regulatory compliance for all cosmetics/skincare products.
Develop HP application strategy and work plan in accordance with business plan and regulatory changes.
- Supervise and coordinate registration vendors on HP dossier preparation and submission, and ensure on time HP application/renewal according to business plan.
- Provide regulatory compliance assessment for upstream technical or commercial innovation from multiple aspects (HP, ingredient, technology, claims, package etc.)
- Monitor changes on regulatory requirements related to HP application, provide timely update and assessment to R&D and Marketing.
- Optimize registration process to be more time and cost effective. Increase registration capability and capacity in CCSC.
- Review and ensure correct compilation of registration docile for submission to the authorities for HP application
- Build up and maintain connection with authorities and KOLs to improve HP application success rate and quality. Coordinate the design and development of Chinese label, and ensure the labeling compliance of finished products.
- Ensure proper and secured maintenance of regulatory database and docile filing
- Assist regulatory affairs manager on handling consumer complaints or post market issues and regulatory issues.
- Provide regulatory censorship on advertisement and commercial communication materials.
- Assist Regulatory affairs manager on communication with relevant authorities for the purpose of better understanding and anticipation of regulations and their impact so as to prepare business actions accordingly
- Assist Regulatory affairs manager on budget setting & control for the department
- Bachelor degree with majority of medicine/pharmacy, chemistry, biology etc.
- Good command of English.
- 5-7 years relevant experience in imported cosmetics or drug registration, familiar with the whole registration process.
- Familiar with cosmetic relevant regulations and technical standards
- Team management and budget management experience
- Good communications and interpersonal skills as well as social capability.
- Self-motivate and good team leader.