South San Francisco, CA (Hybrid - Preferred)
Open to remote
6 month contract
Key Responsibilities:
· Serve as the Global Regulatory Lead on project teams and key sub-teams
· Develop and implement competitive and effective global regulatory strategies for oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
· Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes
· Collaborate with regional and country regulatory affiliates to support ex-US clinical development activities
· Present Regulatory strategies and issues at team and governance meetings
· Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and Health Authority reviewers
· Prepare teams for and lead Health Authority meetings
· Manage and participate in the creation, review, assembly and submission of regulatory documents including INDs and CTAs and amendments, RFIs, annual reports
· Ensure consistency/completeness/adherence to standards for all regulatory submissions
· Coordinate and consult with other departments on the content, review of publication materials, and assembly of regulatory documentation
· Support non-program specific projects as assigned such as department initiatives, business development assessments, clinical assessments, and department training, etc.
Qualifications:
· Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred.
· 5 – 7 (assoc dir)/ 7 – 9 (director) years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required.
· Demonstrated understanding of regulations and guidelines governing oncology drug development and ability to strategically apply to overall drug development
· Demonstrated leadership ability in team settings
· Strong written and verbal communication skills
· Demonstrate expertise and knowledge of oncology and relevant indications
Key Leadership Competencies:
· Builds strong relationships with peers and with partners cross functionally outside of team to enable higher performance
· Learns fast, grasps the 'essence' and can change the course quickly where indicated
· Raises the bar and is never satisfied with the status quo
· Creates a learning environment, opens to suggestions and experimentation for improvement
· Embraces the ideas of others, nurtures innovation and manages innovation to reality
*CO/NYC candidates might not be considered
