Review and assess recently published regulations and policies impacting development of treatments for rare diseases, communicate the impact to management and project teams, and provide training on applicable requirements to scientific staff as required.
Develop strategic responses to policy and regulatory issues that affect the company's marketed and pipeline products; areas of focus include but are not limited to: gene therapy, orphan drugs, clinical trial design, drug development for rare diseases, combination products, orphan drugs, biomarkers, labeling, the voice of the patient in drug development, and PDUFA reauthorization.
Lead teams on generation of comments on draft guidances.
Represent BioMarin on trade and patient association calls and meetings, help shape and steer stakeholder discussion based on company regulatory policy, and generate minutes and follow-up and fulfill commitments.
Provide policy support to regulatory teams ensuring internal awareness of policy landscape and potential impact to development programs and providing regulatory policy advice to support strategy development.
Serve as liaison between the BioMarin and the FDA on regulatory policy and strategy issues, ensuring that communications on both sides are germane, specific and convey all necessary detail.
Attend BioMarin-FDA meetings, follow-up and fulfill commitments.
Represent BioMarin on panels at public conferences and workshops.
Support the preparation for FDA Patient Workshops and Patient-focused meetings.
Work collaboratively with BioMarin's regulatory research, outcomes and patient engagement teams to generate opportunities to collaborate to further support BioMarin programs.
This role reports to Executive Director Regulatory Policy, Research and Engagement, and must interact with internal team members, senior management, regulatory affairs representatives, government affairs representatives, market access representatives, BioMarin subject matter experts, potential partners, and industry organizations.
EXPERIENCE and SKILLS
12+ years of experience in the healthcare, pharmaceutical industry, trade associations, or the Food and Drug Administration.
Regulatory, policy and/or clinical science work experience.
Communication skills, excellent verbal, written and presentation skills.
Very strong attention-to-detail combined with ability to see big picture and understand business need.
Strong collaborative skills, as this position requires close working relationships with both internal and external stakeholders.
A postgraduate degree in science, law or public policy.