Associate Director, Regulatory AffairsLocation 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.
The Associate Director will serve as the Global Regulatory Lead (GRL) for a high priority biological product developed for a rare disease that is approved in the US, has an MAA under review in the EU, and has marketing applications planned in multiple international markets. The position will lead the Global Regulatory Team and, working with the regional regulatory team members, will develop the global regulatory strategy and oversee its execution. Regulatory filing strategy and further clinical development will be a key focus for the role. The Associate Director will serve as the regulatory affairs representative on the corporate product core team and as the primary liaison for the US FDA. Candidates 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.
- Development of Global Regulatory Strategy for a biological product
- Lead the Global Regulatory Team
- Oversee planning, preparation, submission of planned marketing applications
- Oversee maintenance of approved US BLA, including multiple post-marketing clinical studies.
- Oversee planning, preparation, submission and maintenance of INDs and international equivalents
- Provide strategic insight to the core and clinical development teams regarding product development
- Serve as primary liaison with FDA
- Serve as core team member
- Management of 1-2 employees
- Other duties as assigned
- 5-7 years experience in Regulatory Affairs in the biotechnology industry
- Proven ability to manage critical projects as a part of a interdisciplinary team
- Knowledgeable regarding US regulatory marketing application requirements; experience with EU requirements preferred.
- 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
- Prior experience in a product development role and experience with biologic products is desirable
- Skilled at developing product approval strategies
- Outstanding interpersonal and communication (written and verbal) skills
- Experience with managing personnel preferred.
BS degree in life sciences or equivalent
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.