Associate Manager, Regulatory Affairs - RMC / EP
Summary of Job Responsibilities:
1. Lead lifecycle maintenance activities for marketed products. Develop regulatory strategy plans to support successful LCM of marketed products and provide Regulatory expertise to cross-functional teams
2. Ensure timely Regulatory filings and response to HA queries for marketed products. Execute regulatory submission activities for supplemental application, notification filing and annual report for variations of post marketing products.
3. Execute QC testing related activities for supplemental application.
4. Support HA meeting and HA query response.
5. Establish good collaboration with key stakeholders in local, regional, and global organizations.
Dimensions of Job:
1. Regulatory LCM strategy support for marketed products. Execute regulatory submission for supplemental application, notification filing and annual report for variations of post marketing products ensuring all activities following company procedures and local regulations.
2. Execute QC testing related activities for supplemental applications ensuring all activities following company procedures and local regulations.
3. Support HA meeting related activities and HA query response following global procedure and local regulations.
4. Work well with key stakeholders in local, regional, and global organizations.
Principal Accountabilities of Job:
1. Collaborate with local project team, regional and global key stakeholders to prepare dossier and execute submission. Conduct QC testing and support HA consultation meeting related activities and HA query response ensuring timely delivery.
2. Coordinate internal discussion to update local procedures to meet global procedures and local regulations, guidelines if applicable.
3. Develop and improve internal process for operation excellence.
4. Actively lead or involve in review and revision of regulations, guidelines if applicable.
5. Conduct related trainings for operation excellence.
6. Credo based behavior with regulatory compliance.
Key Performance Measures:
1. Timely delivery of regulatory submission and related activities with high quality.
2. Keep compliant with company procedures and local regulations.
3. Good communication skill, risk management mindset and learning agility.
1. Bachelor’s or above degree in chemistry, pharmaceutics, biology, or a related life-science discipline. Advanced degree is preferred.
2. Minimum of 2 years’ experience in a multi-national pharmaceutical company is preferred.
3. Strong oral & written communication skill; ability to work under pressure.
4. In-depth knowledge of regulatory environment, regulations and guidelines.
5. Experienced in working with cross-functional team for submission strategy and implementation.
6. Proficiency in verbal and written English; good presentation skill, good computer skill.