Director/Associate Director, Regulatory Affairs Clin/Non-ClinLocation San Rafael, California Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
Regulatory Leader focused on clinical and nonclinical aspects of domestic and international regulatory affairs for an early-stage small molecule and supporting an early-stage gene therapy development program. Leads interdisciplinary regulatory team responsible for defining and implementing global regulatory strategy to achieve objectives in line with corporate goals. Provides regulatory leadership on cross-functional development teams and leads interactions with global health authorities. Candidate must have proven expertise in working collaboratively and driving for results in a team setting as well as demonstrated skills in communicating with internal and external stakeholders.
- Lead interdisciplinary regulatory team in establishing global regulatory strategy for early-stage development programs
- Oversee planning, preparation, and submission of clinical trial applications and potentially marketing applications in the US and internationally
- Provide strategic regulatory insight to the core, nonclinical and clinical development teams regarding product development
- Lead interactions with FDA and support global regulatory agency interactions
- Expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs.
- Communicate with regulatory consultants regarding product development plans
- Perform other duties as assigned
- 7-10 years of experience in Regulatory Affairs in the biotechnology industry
- Proven ability to manage critical projects as a part of an interdisciplinary team
- Knowledgeable regarding IND/CTA and marketing application requirements
- Proven ability to successfully interact with regulatory authorities
- Prior experience managing regulatory submissions with the ability to successfully manage projects to deadlines
- Thorough understanding of relevant drug development regulations and guidelines
- Prefer prior experience in a product development role and experience with rare diseases, and small molecule and/or gene therapy products is desirable
- History of achieving regulatory goals in ambiguous and sometimes challenging situations, and solving regulatory problems while exhibiting superior judgment
- Outstanding interpersonal and communication (written and verbal) skills
- MS degree or higher in a life science with a minimum of 7 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry with a clinical and nonclinical emphasis, or BS degree in life sciences or equivalent with 7-10 years of experience
- Fluent in English (written and spoken)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.