Advisor, Regulatory AffairsLocation 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.
**Note** Position can be located in SRC or D.C.
Support regulatory strategy development by responding to and anticipating queries and research requests from GRL, regulatory stakeholders, and other BioMarin stakeholders on assigned programs (e.g. researching regulatory landscape and precedents), and if applicable, performing research on due diligence programs. Responsible for the ongoing monitoring and communication of regulatory trends, agency actions, and relevant decisions.
- Monitor and assess competitor regulatory strategies, perform searches across regulatory agency web sites, reviews, and using available databases to identify regulatory approval, labeling and clinical trial design precedent to support US and EU marketing license applications
- Perform regulatory pathways analysis and develop agency knowledge and insights
- Compile and analyze data and metrics for reports on regulatory pathways
- Identify the degree of clinical evidence supporting FDA and EMA marketing license applications across assigned therapeutic areas
- Identify the issues raised during reviews and the approaches used to resolve the issues raised by health authorities
- Respond to queries and research requests regarding regulatory precedents and competitor strategies
- Generate regulatory research reports detailing the scope of the search, findings, key messages and conclusions
- Keep management and internal stakeholders apprised of FDA and EMA decisions and proposals, regulatory developments, and new regulatory trends
- Appropriately communicate research findings based on audience needs across activities
- Contribute to BioMarin regulatory strategy through regulatory project team representation and in close collaboration with the regulatory project team leader
- Responsible for performing research on due diligence programs when assigned.
- Substantial experience in the healthcare industry (15+ years), with a solid background of experience in Regulatory Affairs.
- The candidate must have substantial regulatory/clinical Phase I to Phase III development experience and have worked on a minimum of at least one marketing application approvals.
- Extensive research, analytical skills and attention-to-details are essential to lead research projects and critique reports.
- Extensive experience in identifying trends in regulatory research information.
- Strong understanding of US and European Regulatory Affairs and procedures.
- Demonstration of strong critical thinking abilities is essential.
- Proven ability to identify unique and creative regulatory strategies appropriate for the FDA and EMA approval of both biologics and small molecules.
- Strong collaborative skills, as this position requires close working relationships with both internal stakeholders.
- Experience in using regulatory data bases (e.g. Cortellis, Pharmapendium) is beneficial.
- Excellent verbal, written and presentation skills.
A BS in a life science is required, a Masters or PhD is an advantage.
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.