Senior Associate, Regulatory Affairs

Location:  San Rafael, California Category: Regulatory


BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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 will play a key role in preparing US and international regulatory filings for both early and late-stage products designed to treat rare, unmet medical conditions. The position will focus on the clinical and nonclinical aspects of regulatory affairs and will work closely with cross-functional team members.



  • Prepare, submit, and maintain domestic and international regulatory filings, both pre and post approval

  • Attend project team meetings across functional areas

  • Coordinate meetings with regulatory authorities

  • Assist with development strategy

  • Support the filing, review, and approval of global license applications

  • Supporting the preparation and filing of INDs and CTAs

  • Support for multiple projects if necessary

  • Other duties as assigned



Required Skills:

  • At least 2-4 years of experience in Regulatory Affairs in the biotechnology industry

  • Proven ability to manage critical projects with a minimum of supervision

  • Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines

  • Prior experience in a product development role

  • Proficient with computer and standard software programs

  • Strong interpersonal and communication (written and verbal) skills

  • Effective task planning and coordination abilities

  • Demonstrated good judgment

  • Capable of working with an interdisciplinary team

  • Strong understanding of US FDA regulations applicable to therapeutic products.


    While not required, but the ideal candidate have:

  • Prior experience preparing ex-US CTAs.

  • Prior experience with orphan products.



BS degree (advanced degree desirable) in life sciences or equivalent.

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.