Mgr, Regulatory Affairs

Position Title : RA Manager, Drug Project and RI

Report to: Head of RA, Drug Project and RI

Responsibilities:
- Develop and execute regulatory strategies for multiple complex programs and platforms related to local manufacturing projects as well as import drug projects according to responsible therapeutic areas.
- Develop and document sound regulatory decisions and justifications for assigned projects.
- Represent or lead cross-functional team on assigned projects.
- Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
- Establish appropriate communication as internal as with cross functions primarily at project level, and also as external as with Health Authority.
- Response for assigned regulatory intelligence activity: monitor applicable regulatory requirements; assure regulatory compliance with external standards, perform gap analysis and remediation plan; policy interpretations and presentations to local and global colleagues.
- Response for assigned regulation & guideline shaping activity: develop external engagement activities with internal and external stakeholders, to build long-term and win-win relationship/partnership with external stakeholders.

Qualifications:

1. Bachelor's degree or above in Pharmaceutical related discipline.
2. With minimum of 15 years' work experience, incl. at least 5 years' RA experience in MNC.
3. Sound basis of Regulatory knowledge and Scientific Knowledge.
4. Ability to manage complex projects and timelines in a matrix team environment and problem solving.
5. Ability to insure projects on time delivery with high quality.
6. Ability to independently identify regulatory strategy and risk with mitigation plan.
7. Strong oral and written communication and presentation skills.
8. Strong interpersonal skills incl. strong coordinate skills and experience in interacting with regulatory authorities.