Executive Director, Global Regulatory PolicyLocation Washington DC, District of Columbia 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 Executive Director, Global Regulatory Policy and Engagement will lead the development and implementation of BioMarin’s strategy on regulatory policies that impact development of treatments for rare diseases, including gene therapies. The successful candidate will work cross-functionally to develop and implement strategic plans to advance regulatory policy issues and engage regulatory authorities.
Primary Responsibilities Include
- Lead Global Regulatory Policy team in developing regulatory policy strategy for each region, lead team in implementing regulatory policy strategy
- Advance BioMarin’s position on key regulatory policy issues by engaging regulatory authorities, trade associations and internal subject matter experts.
- Assist and advise WWRD leadership on regulatory policy issues related to the company’s portfolio and pipeline, including establishing priorities, and proactively developing and executing regulatory policy strategic plans.
- Lead team in developing strategic responses to regulatory and policy issues that may impact the company, including: gene therapy, rare diseases, clinical trial design, real-world evidence and patient-focused drug development, among others.
- Provide regulatory policy insights and support across the company, ensuring internal awareness of regulatory policy landscape.
- Provide feedback on regulatory landscape to inform regulatory strategy.
- Engage with regulatory authorities and fulfill commitments on regulatory policy issues, including regulatory policy meetings, workshops and patient-focused meetings.
- Provide oversight of regulatory policy assessments including impact analysis.
- Lead team’s analysis of guidances and comment development and submission.
- Represent BioMarin as an expert at external events including panels, briefings, conferences, etc.
- Lead cross-functional strategy development with Government Affairs, Compliance, EU, US and International teams
Education And Skills Requirements
- 15+ years of experience in the healthcare, pharmaceutical industry, trade associations, or the Food and Drug Administration.
- Background as either an FDA reviewer or direct drug development experience in industry is required
- Outlook as a visionary thinker with a sense of urgency is required
- Good understanding of global regulatory landscape (US, EU, LATAM, APAC, MEACIS) is a plus
- Experience with rare disease preferred and gene therapy a plus.
- Proven teamwork and collaboration skills, with a demonstrated ability to work collaboratively with colleagues, industry trade associations, and influential policy organizations.
- A high level of energy and passion toward patients, science and public health.
- Self-initiating, well-organized and capable of managing multiple projects simultaneously and independently.
- Demonstrated ability to develop innovative solutions.
- Bachelor’s Degree required, advanced degree required.
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.