Associate Director, US Regulatory Policy

Location:  Washington, District Of Columbia Category: Regulatory

Description

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.

RESPONSIBILITIES

  • Review and assess recently published global 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: orphan drugs, biomarkers, surrogate endpoints, benefit-risk assessment, labeling, gene therapy products, the voice of the patient in drug development, combination products, and PDUFA reauthorization.
  • Lead teams on generation of comments on draft guidances and proposed rules, and other topics that FDA may seek comments or open public dockets for, e.g. associated with a public meeting.
  • Represent BioMarin on industry trade and patient association calls and meetings, help shape and steer stakeholder discussion based on company regulatory policy and priorities, 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.
  • Work collaboratively with BioMarin’s regulatory policy, research, outcomes and patient engagement teams to generate opportunities to collaborate to further support BioMarin programs.
  • This role reports to the Head of Global Regulatory Policy, and must interact with internal policy team members, regulatory affairs representatives, potential partners, and industry organizations.

 

 

EXPERIENCE and SKILLS

  • 12+ years of experience in the healthcare, pharmaceutical industry or the Food and Drug Administration.
  • Regulatory, policy and clinical science work experience.
  • Organizational skills.
  • 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.

 

EDUCATION

  • A postgraduate degree in science, nursing or degree in public health, policy or law.

 

Required location: This is a remote position.  Washington DC area



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.