Johnson & Johnson Careers
Manager, Regulatory affairs
Requisition ID: 1805661774W
- Lead regulatory strategy development for R&D portfolios and marketed products LCM for assigned projects
- Represent RA and provide regulatory strategy input for China compound teams; execute CTA & NDA/BLA filings; lead CDE consultation preparation activities and meeting minute’s preparation.
- Represent RA and provide regulatory strategy input to support successful LCM of responsible marketed products including line extensions and variations, and provide Regulatory expertise to local product and cross-functional teams
- Ensure timely Regulatory filings and response to HA queries
- Provide mentoring and coaching to junior staff members, if applicable
- Establish strong relationship with regulatory authority and key stakeholders in the local, regional and global organization
- Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred.
- Minimum of 5-8 years regulatory affair experience in a multinational pharmaceutical company. At least 2 years’ experience in managerial role is preferred.
- Strong oral & written communication skill; Strong leadership capability and ability to work under pressure.
- In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration.
- Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.
- Proficiency in verbal and written English; good computer skill, good presentation skill.
J&J (China) Investments Ltd A- Beijing Branch (7075)