Sr. RA Manager
Your tasks and responsibilities
1. Lead a regulatory team and work with global regulatory teams
and local cross functional teams to ensure the submission of
license applications and renewals on time, and the assessment of
the impact product changes have on the status of regulatory
2. Interpret the latest regulatory requirements and determine regulatory strategies to obtain license registration and renewal approvals.
3. Work with both local and global regulatory team members to ensure pharmaceutical products documents are complete, accurate and consistent with Chinese regulatory requirements and BCC global quality management system.
4. Ensure team members compliance with all applicable regulations and BCC policies.
5. Provide regulatory affairs support during internal and external audits.
6. Stay current with the latest new regulatory policies on OTC drugs, medical devices in China.
7. Actively participate different industry regulatory associations related to OTC drugs, medical devices and influence policy changes and development in China.
8. Develop local external regulatory KOL network and maintain constructive relationship with China regulatory bodies to enhance regulatory intelligence and overall regulatory approval rate.
9. Develop regulatory talents and team competences on OTC drugs, medical devices.
10. Provide coaching and mentoring to junior regulatory associates.
1. More than 10 years of proven track record of regulatory experience with broad business exposure in the pharmaceutical industry. At least 3 years people management experience. Past work experience in China is mandatory, preferably in the pharmaceuticals industry, OTC market. Consumer and market insights are essential. A good understanding of
international corporate culture is helpful
2. Bachelor or above degree of pharmaceutical, medical, chemistry, or related life-science discipline;
3. Well understand China registration policies and procedure on drug, or medical device etc., good relationship governments
4. Excellent communication skills, verbal and written, and strong analytical skills are required.
5. Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management
6. Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and
external strategic partners.
7. Fluent English in verbal and written; good computer skill.