Title: Director, Regulatory Affairs
Location: Menlo Park, CA
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity.
This position is specifically responsible for the oversight of regional and/or global regulatory submissions and ensures strategies are in accordance with therapeutic area direction and corporate objectives. The Director, Regulatory Affairs, will be responsible for leading one or more drug development programs, with specific emphasis on global regulatory strategy, regulatory submissions, and interaction with global regulatory authorities. S/he must have a good understanding of clinical development strategies and health authority expectations for novel and complex oncology programs. The position will report to the Vice President, Regulatory Affairs. as well as support inspection readiness for Forty Seven Inc.
These may include, but are not limited to, the following; other duties may be assigned
- Provides strategic direction and oversight in the preparation of regulatory submissions especially the filing of the BLA of lead compound
- Leads cross functional project teams to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex programs by providing expert and effective project management oversight, direction, planning, and execution
- Acts as key liaison for ordering publications, guidelines, FOI requests, etc. for the department
- Sets up training sessions for appropriate individuals and provides ongoing support as needed
- Work closely with functional leaders to create the optimal development path for the lead product candidates, negotiate optimal development paths within cross-functional teams and with health authorities, and execute clinical-regulatory development plans on-time and while managing all identified risks.
- Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
- Leads cross-functional teams in preparing for health authority meetings.
- Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
- Works within the department and with other functional areas on process improvements.
- Lends regulatory expertise and policy support for good pharmaceutical development practices (GCPs, GMPs and GLPs)
- Mentor junior staff as needed
Education & Experience:
- BS degree in life sciences. Advanced degree preferred.
- Minimum 10 years' experience in regulatory affairs
- Late‑stage experience in oncology drug development.
- Experienced in the creation, submission, and negotiation of market applications preferred.
- Experienced in creating and negotiating the clinical-regulatory aspects of oncology programs.
- Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents. E.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries within agreed timelines.
- Able to simultaneously manage multiple projects and submissions, with flexibility to pivot based on new data, program changes, and/or external influences.
- High attention to detail and accuracy.
- High organizational and planning skills.
- Able to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships.
- Excellent interpersonal, verbal and written communication skills
- Position may require occasional evening and/or weekend commitment
- Position may require working with biological and/or chemical hazards
- Position may require occasional travel (~25%), domestic and international.