Manager, Regulatory Affairs (Clinical/Nonclinical)Location 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.
This position focuses on the clinical/nonclinical aspects of global regulatory affairs for a high-profile Phase 3 development project. This individual will execute the strategy and implementation of the development program for ROW including the US. Duties for other projects and management of regulatory staff may also be assigned
- Oversee planning, preparation, and submission of ROW CTAs planned for 2018/2019.
- Oversee planning, preparation, and submission of IND and international equivalent amendments.
- Provide strategic insight to the study teams regarding product development.
- Communicating with regulatory consultants and CROs regarding product development plans.
- Assist in the management of marketing applications.
- Potential for future management of employees.
- Other duties as assigned.
- At least four years experience in Regulatory Affairs in the biotechnology industry
- Skilled at gathering regulatory information and developing product approval strategies
- Proven ability to manage critical projects as a part of an interdisciplinary team
- Experience preparing ex-US CTAs with authorities.
- Proven ability to successfully interact with regulatory authorities, including leading the preparation of key regulatory meetings.
- Prior experience managing regulatory submissions with the ability to successfully manage projects to deadlines.
- Prior experience leading the development of complex briefing documents
- Thorough understanding of relevant drug development regulations and guidelines
- Proficient with computer and standard software programs
- Outstanding interpersonal and communication (written and verbal) skills
- Effective task planning and coordination abilities
While not required, but the ideal candidate have:
- Prior experience serving as primary sponsor contact for FDA.
- Prior experience leading team preparations for health authority interactions.
BS degree (advanced degree desirable) in life sciences or experience in drug development that allows for sufficient knowledge in this area.
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.