- Serve as an empowered US Regulatory Lead of the assets for the Therapeutic Group(s) focusing on Immunology and Immuno-oncology;
- Serve as point of contact for Regulatory Agencies between US and China teams;
- Lead US IND filings with high quality and expedited fashion. Develop, review and complete submission documents in collaboration with other functional disciplines. Achieve this in a collaborative and trusting relationship with regulators and other external stakeholders;
- Assist in preparation and submission of INDs and IND amendments;
- Assist in preparation and submission of international Clinical Trial Applications;
- Participate in the development and implementation of short- and long-term Regulatory plans for key projects;
- Guide Nonclinical, CMC and Clinical personnel about the content and format requirements for INDs, CTAs and NDAs/BLAs;
- Perform nonclinical, CMC and clinical GAP analyses of dossiers being considered for registration of products in the U.S.;
- Lead preparations and delivery of FDA communications with Clinical Development Team;
- Provides regulatory due diligence into business opportunities as needed.
- Regulatory Affairs experience in drug development and/or registration activities is a must.
- Minimum of a Bachelor’s Degree in an applied science field. Ph.D degree is highly preferred.
- Outstanding working understanding of the U.S. regulatory environment.
All your information will be kept confidential according to EEO guidelines.