Director, Regulatory Affairs
1 Tower Place Suite 850 South San Francisco, CA 94080 US
Client is a development-stage company with a novel platform technology enabling oral delivery of therapeutic biologic products. Client' s Senior Vice President of Regulatory Affairs is searching for a dynamic, experienced Regulatory professional who is excited about translating this technical advance into new medicinal products.
Regulatory Affairs at client is working with the development teams to bring novel oral biologic therapies to market. As the Director of Regulatory Affairs reporting to the SVP, you will lead efforts to develop global regulatory strategies and execution of Team-agreed plans. The Regulatory Director will lead the planning and preparation along with the subject matter experts Nonclinical and Clinical sections for regulatory submissions including INDs, IMPDs, and eventually the BLAs/MAAs for pipeline products. You will provide clinical and nonclinical regulatory guidance to several clinical project teams to ensure compliance with regulations, guidelines, and industry standards. You will participate in the evaluation of protocols, investigational brochures, clinical and nonclinical sections to regulatory filings and provide guidance for optimal regulatory outcomes.
- Represent Regulatory Affairs as the Regulatory nonclinical and clinical subject matter expert in our development teams.
- Manage a staff including manager and senior regulatory associate levels.
- Be the key liaison and provide regulatory guidance to colleagues in clinical and nonclinical teams.
- Research and interpret global regulations and provide strategic direction and regulatory guidance to product development.
- Develop practical, workable submissions plans to support clinical and nonclinical activities enabling clinical trials and marketing authorizations.
- Develop and maintain detailed timelines for regulatory activities and submissions and assure planning and coordination of activities is executed to plan.
- Prepare, review, coordinate with subject matter expert authors to manage regulatory submissions. These include original and amended INDs/IMPDs, annual reports, agency meeting briefing documents and clinical and nonclinical sections of the BLA/MAA.
- Manage all regulatory submission documents in collaboration with AMT staff and external vendors.
**CO candidates may not be considered