- Provides regulatory leadership, and develop global regulatory and clinical strategies for assigned development projects or marketed products.
- Provide strategic input and regulatory advice to the project teams on development programs.
- Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks
- Provide oversight of regulatory timelines and track deliverables
- Interface with functional areas to identify and obtain information required for regulatory submissions
- Develop and/or review regulatory documents to ensure that all submissions are of high quality
- Prepare/coordinate/review the nonclinical and clinical content of IND/CTAs, protocol/information amendments and NDA/BLA/MAA
- Lead the preparation and filing of the regulatory applications (IND/CTA, NDA/BLA/MAA).
- Provide regulatory oversight of maintenance submissions (DSUR, PSUR, Annual Reports, etc) of assigned projects in multiple countries
- Interface with global regulatory authorities and consultants as needed
- Lead the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications
- Lead the preparation of responses to questions from Regulatory Authorities
- Minimum Master's degree in Pharmacy, Biology, Chemistry or related healthcare functional area. Advanced degree (PhD, MD or Pharm D) preferred.
- Strong scientific background with at least 10 years of experience in Clinical Regulatory Affairs in the biotechnology or pharmaceutical industries, related experience may be considered
- Extensive experience in preparation, submission and approval of INDs/CTAs and marketing applications (NDA/BLA/MAA).
- Proven ability to successfully manage major submissions and critical projects timelines.
- Experience in addressing clinical-related regulatory queries from global health authorities
- Experience with leadership role in HA negotiations.
- Excellent medical writing, communication and management skills.
- Regulatory Affairs Certification (RAC) preferred
- Must speak Mandarin fluently