Associate Director, Regulatory Affairs
Location: South San Francisco, CA
Position type: Full-time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics for patients with serious unmet medical needs. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development.
We currently have three protein therapeutics in clinical trials:
- Cabiralizumab: a monoclonal antibody that inhibits the CSF-1 receptor and is being studied in multiple tumor settings and pigmented villonodular synovitis (PVNS)
- FPA144: a monoclonal antibody targeting FGFR2b for selected gastric cancers
- FP-1039: a FGF ligand trap for mesothelioma
On the strength of our unique discovery platform and capabilities, we have entered into strategic collaborations with leading global pharmaceutical companies. We currently have three active research collaborations with Bristol-Myers Squibb, GlaxoSmithKline and UCB Pharma, S.A.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. These values are reflected in our people and our products. We value our culture of openness, collaboration and productivity. Discover more about FivePrime at www.fiveprime.com.
FivePrime Therapeutics, Inc. is seeking a motivated and ambitious individual to lead the development and implementation of the CMC (Chemistry, Manufacturing and Controls) regulatory strategy for our programs. The individual will represent Regulatory Affairs and work closely with cross-functional teams. This is an Associate Director level role reporting to the Vice President of Regulatory Affairs.
Responsibilities will include:
- Develop and implement CMC regulatory affairs strategy to support development programs.
- Plan regulatory milestones over the product lifecycle in coordination with cross-functional interdependencies.
- Serve as regulatory representative for select product development programs, including regulatory liaison with business partner(s), the FDA and other regulatory agencies.
- Manage relationships with business stakeholders with responsibilities in process development, analytical development and quality to provide CMC regulatory support
- Conduct regulatory risk assessments including risk mitigation.
- Lead cross-functional team to develop technically complex regulatory submissions.
- Review technical reports and summary documents (CMC) for adherence to regulatory guidelines, strategies, and commitments.
- Recommend regulatory policies to assure adherence to FDA requirements. Contribute to the modification, development and implementation of company practices and policies for Regulatory Affairs.
- Provide regulatory expertise and policy support; educate others on regulatory policy and environment and impact to internal organization.
- BA/BS degree in Biology or Biochemistry; advanced degree desirable.
- ≥10 years of experience working in a regulated environment
- Strong strategic regulatory expertise across phases of drug development
- Extensive knowledge of FDA regulations, practices and ICH guidances
- Strong knowledge of global health authority regulations and practices
- Experience leading, developing and implementing complex CMC regulatory strategy
- Experience in managing major regulatory filing(s) such as IND or BLA
- Direct experience in biologics
- Experience with nonclinical/clinical and/or companion diagnostics a plus
- Excellent verbal, written, negotiation, influence and interpersonal communication skills
- Previous experience in leading cross-functional teams
Please upload your cover letter and resume