Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Sr. RA Manager
Your tasks and responsibilities
- 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 licenses.
- Interpret the latest regulatory requirements and determine regulatory strategies to obtain license registration and renewal approvals.
- Work with both local and global regulatory team members to ensure pharmaceutical products documents are complete, accurate and consistent with Chinese regulatory requirements and CH global quality management system.
- Ensure team members compliance with all applicable regulations and CH policies.
- Provide regulatory affairs support during internal and external audits.
- Stay current with the latest new regulatory policies on OTC drugs, nutrition, health food, cosmetics etc. in China.
- Actively participate different industry regulatory associations related to OTC drugs, nutrition, health food, cosmetics and influence policy changes and development in China.
- Develop local external regulatory KOL network and maintain constructive relationship with China regulatory bodies to enhance regulatory intelligence and overall regulatory approval rate.
- Develop regulatory talents and team competences on a wide spectrum of categories.
- Provide coaching and mentoring to junior regulatory associates.
Who you are
- 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
- Bachelor or above degree of pharmaceutical, medical, chemistry, or related life-science discipline;
- Well understand China registration policies and procedure on drug, cosmetics, health food, nutrition etc. and closely work with government bauthorities
- Excellent communication skills, verbal and written, and strong analytical skills are required.
- Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills
- Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners.
- Fluent English in verbal and written; good computer skill.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Location: BeiJing, Shanghai
Functional Area: [sap_fa_32]
Entry Level: 5