Summary of Job Responsibilities:
1. Lead regulatory strategy development for R&D portfolios and marketed products LCM in responsible TAs
2. Represent RA and provide regulatory strategy input for Development teams at C-TASTe level; lead CDE consultations meetings and all RA support in advancing pipeline to market
3. 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
4. Ensure timely Regulatory filings and response to HA queries
5. Provide mentoring and coaching to junior staff members
6. Establish strong relationship with regulatory authority and key stakeholders in the local, regional and global organization
Dimensions of Job:
1. Regulatory strategic oversight and support for R&D portfolios including registration pathway and acceleration strategy, as well as input to R&D functions and C-TASTe and/or China compound teams
2. Regulatory LCM strategy support for marketed products in responsible TAs, as well as input to BU and product teams
3. Liaise with Regulatory agency
4. Regulatory process development & resource planning
Principal Accountabilities of Job:
1. Collaborate with global, regional and local product teams to develop and implement registration plan and regulatory strategy.
2. Oversees regulatory activities & review critical submissions in responsible TAs
3. Ensure timely Regulatory submission and team response efforts to HA request.
4. Lead cross-functional preparation, rehearsal and facilitate CDE consultation meetings.
5. Interact with HA review divisions.
6. Actively lead or involve in review and revision of regulations, guidelines.
7. Develop internal regulatory process for effective operation.
8. Credo based behavior with regulatory compliance excellence.
1. Regulatory strategy development and execution
2. Timely delivery of regulatory submissions with high quality
3. Strong HA connection and leadership
4. Others: Strategic thinking, Cross-functional collaboration, Crisis management, People development
1. Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred.
2. Minimum of 10 years regulatory affair experience including 5 years in managerial role in a multinational pharmaceutical company.
3. Strong oral & written communication skill; excellent leadership capability and ability to work under pressure. Demonstrated ability to effectively manage and lead a team.
4. In-depth knowledge of regulatory environment, regulations and guidelines. Experience in HA interactions and pharmaceutical product registration.
5. Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.
6. Proficiency in verbal and written English; good computer skill, good presentation skill.
J&J (China) Investments Ltd A- Beijing Branch (7075)