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Director, Regulatory Affairs

Location San Rafael, California
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. 

SUMMARY

Global Regulatory Leader focused on clinical and nonclinical aspects of domestic and international regulatory affairs for several commercial programs.  Leads a multi-disciplinary regulatory team responsible for defining and implementing global regulatory strategy.  Provides regulatory leadership on cross-functional development teams.  Oversee and mentor a small team of regulatory professionals to achieve regulatory objectives in line with corporate goals.  Leads interactions with global health authorities and corporate partners.  Continues to expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics. 

RESPONSIBILITIES

  • Lead interdisciplinary regulatory team in establishing global regulatory strategy for several commercial programs
  • Oversee planning, preparation, and submission and maintenance of clinical trial applications and marketing applications in the US and internationally
  • Provide strategic regulatory insight to the clinical/medical teams regarding product development
  • Oversee the maintenance of US product licenses and fulfillment of PMRs/PMCs
  • Lead interactions with regulatory health authorities
  • Manage and mentor a small team of regulatory professionals
  • Communicate with regulatory consultants regarding product development plans
  • Interact with executive leadership team to discuss global regulatory plans

EDUCATION

  • MS degree or higher in a life science with a minimum of 8 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry with a clinical and nonclinical emphasis, or
  • Bachelor's degree with 10+ years of experience described above

EXPERIENCE

Required

  • Minimum of 4 years of experience in managing regulatory staff
  • Skilled at gathering supportive information and developing product approval strategies
  • Demonstrated leadership in defining novel approaches to product development and approval
  • Proven track record of managing critical projects as a part of an interdisciplinary team
  • History of achieving regulatory goals in ambiguous and sometimes challenging situations
  • Proven track record of successfully interacting and negotiating with regulatory health authorities
  • Prior experience leading cross-functional teams in the coordination of regulatory submissions and successfully managing projects to deadlines
  • Thorough understanding of global regulatory environment and relevant drug development regulations and guidelines
  • Outstanding interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities
  • History of solving regulatory problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Preferred

  • Rare disease experience is desirable
  • Prior experience with both biologics and small molecules is desirable
  • US and international experience preferred


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.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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