HireDiversity

Beijing, CN

CMC Regulatory Affairs Director-0000082I

Description

Janssen Pharmaceutical Research & Development, L.L.C.,a member of the Johnson & Johnson Family of Companies, is recruiting for a CMC Regulatory Affairs Director to be located in China.

Janssen Pharmaceutical Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The China CMC Regulatory Affairs Director is responsible for developing CMC regulatory strategies and content plans supporting chemical and biological product filings across multiple Registration Categories in China. His/her primarily responsibilities will initially focus on the development of local CMC regulatory strategies and content plans across the lifecycle for products imported into China It is anticipated that responsibilities will eventually expand to include a leadership role on behalf of Global CMC Regulatory Affairs in supporting the global registration of chemical and biological products developed by the China R&D team. Based on a broad regulatory and technical expertise, he/she will also provide guidance to local, regional and/or global associates ensuring that CMC regulatory and development strategies are consistent with evolving expectations of health authorities worldwide.

Qualifications


BS required with 10+ years of experience, MS with 8+ years of experience or Ph.D. with 6+ years of experience. Demonstrated ability to communicate regulatory requirements. High-level verbal and written communication skills. Communicates cross-functionally and cross-company as well and presents and defends CMC management-approved regulatory strategy and opinion to corporate project teams. Demonstrates model behavior that understands what the priorities are and encourages others to drive for results. Experience leading interactions with Health Authorities. Strong knowledge of local and global HA laws, regulations, guidance and global regulation submission routes available for new study drugs. Detailed understanding of competitors in the area and what they are doing in early/late development. Solid understanding of biology and chemistry relevant to therapeutic area. Experience developing regulatory strategies and seen as an expert on product development and how it is applied.

Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Medical China (7052)
Travel:Yes, 50% of the time