(Associate/Senior) Manager, Regulatory Affairs - EP
Summary of Job Responsibilities:
1. Develop regulatory strategy plans tolead successful life cycle management (LCM) of marketed products including line extensions and variations, and provide Regulatory expertise to local products and cross-functional teams
2. Ensure timely Regulatory filings and response to HA queries for marketed products
3. Provide mentoring and coaching to junior staff members
4. Establish strong relationship with HA and key stakeholders in the local, regional and global organization
5. Perform with high quality and compliance.
Dimensions of Job:
1. Regulatory LCM strategy support for marketed products
2. Regulatory strategy 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 strategy.
2. Oversees regulatory activities & review critical submissions for assigned projects.
3. Ensure timely Regulatory submission and team response efforts to HA query.
4. Lead cross-functional preparation for 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.
Key Performance Measures:
1. Effectively set Regulatory strategy
2. Timely delivery of regulatory submissions with high quality
3. Good HA connection and leadership
4. Others: Crisis management, people development, if applicable
1. Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred.
2. Minimum of 5-8 years regulatory affair experience in a multinational pharmaceutical company. At least 2 years’ experience in managerial role is preferred.
3. Strong oral & written communication skill; Strong leadership capability and ability to work under pressure.
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.