Director, Regulatory Clinical/NonclinicalLocation 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 Director will serve as the Clinical/Nonclinical lead for a late stage clinical development program in rare disease. The position will participate on the Global Regulatory Team and be responsible for developing and executing the clinical/nonclinical regulatory strategy.
The Director will serve 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.
- Develop and implement clinical/nonclinical regulatory strategies to support product development, marketing applications and post-approval activities
- Lead and participate in the creation, review, assembly and submission of regulatory documentations such as, but not limited to, NDA, IND/CTAs, expedited program designations, orphan drug applications
- Lead planning, preparation, submission and maintenance of IND/CTAs
- Provide strategic insight to the GRT regarding product development
- Serve as primary liaison with US FDA
- Management of 1-2 employees
- Other duties as assigned
- 5-7yrs. experience in Regulatory Affairs in the biotechnology industry
- Prior experience with NDA filings, preferred
- Proven ability to manage critical projects as a part of an interdisciplinary team
- Knowledgeable regarding US regulatory 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
- Prior experience in a product development role
- Skilled at developing product approval strategies
- Experience with managing personnel preferred.
- Exceptional self-management ability; Highly organized with attention to detail
- Outstanding interpersonal and communication (written and verbal) skills
- Ability to travel as needed for interactions with Health Authorities or as determined by the business
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.