Manager, Regulatory Research & Intelligence
San Rafael, CA
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard \u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarin\u2019s 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 or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients\u2019 lives. Responsibilities Analyst role for Regulatory Research & Intelligence (RRI) includes: Supporting senior regulatory research staff involved in examining regulatory strategy and precedence for marketing applications in US, EU, and Japan including: compiling and analyzing data/metrics, dissemination of research, assisting with presentations and archiving research outputs. Performing searches across regulatory agency websites, reviews (EPARS, SBAs), and use available databases to identify regulatory approval, labeling and clinical trial design precedence as required by research queries. Keeping other RRI team members apprised of FDA, EMA and PMDA product-related opinions, and regulatory trends. Maintaining RRI trackers and calendars for regions of interest. These cover, but are not limited to, expedited designations and drug approvals in the US, EU and Japan, and regulatory events and milestones.\u00A0Education & Experience 3 years of experience in healthcare (e.g., qualified pharmacist) or the healthcare industry, ideally including at least 1 year of experience in Regulatory Affairs. Experience in Regulatory Intelligence or Competitive Intelligence would be a plus, but training would be given. Attention-to-detail is essential in maintaining regulatory trackers and supporting research activities. Strong collaborative skills, as this position requires close working relationships with internal stakeholders. Aptitude with MS Office or equivalent is essential Experience/Knowledge of the following would be beneficial: Researching and analyzing regulatory data (US, EU, and Japan) Use of regulatory databases (e.g., Cortellis, Pharmapendium) Identifying trends in regulatory research information Knowledge of drug development processA Masters degree in life science is preferred, BSc as a minimum is required. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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