Associate Director, Regulatory Research

Location:  San Rafael, California

Description

 

 

 

RESPONSIBILITIES

  • Investigate and analyze regulatory precedence for FDA and EMA marketing application approvals across several therapeutic areas.

  • Evaluate the totality of evidence used to support FDA and EMA marketing applications.

  • Highlight and address, agency review comments, issues and trends that may be relevant to BioMarin development programs.

  • Provide recommendations to project teams and senior management on regulatory pathways and development programs including clinical trial designs to support license marketing applications and applications for investigational products.

  • Evaluate the impact of changes in the regulatory environment and regulatory trends.

  • Keep senior management apprised of the implications of FDA and EMA regulatory decisions and proposals.

  • The candidate must interact with regulatory research and other internal team members, senior management, regulatory affairs representatives, and potentially industry organizations.

 

EXPERIENCE AND SKILLS

  • 12+ years of experience in the healthcare industry, including at least 8 years of experience in Regulatory Affairs is required.

  • The candidate must have substantial regulatory/clinical Phase I to Phase III development experience.

  • Extensive research and analytical skills and attention to details are essential to thoroughly research and document the details of the development programs.

  • Experience in identifying trends in regulatory research information.

  • Experience in European Regulatory Affairs and procedures is beneficial.

  • Proven ability to identify unique and creative regulatory strategies appropriate for the FDA and EMA approval of both biologics and small molecules is an essential requirement.

  • Strong collaborative skills, as this position requires close working relationships with both internal and external stakeholders.

  • Experience in using regulatory data bases (e.g. Cortellis, Pharmapendium) would be a plus.

  • Excellent verbal, written and presentation skills.

 

EDUCATION

  • A PharmD or PhD in a life science is required.