Sr. Regulatory Policy Director

Role Summary

Leads the Regulatory Policy function responsible for proactively monitoring, analyzing and summarizing developments in regulations and guidance impacting pharmaceutical development for Neurocrine Biosciences’ products and pipeline, primarily for the US. Informs and influences policy matters with external stakeholders, and establishes partnerships with Government Affairs, Public Policy and Patient Advocacy organizations to support relevant policy matters. Ensures that substantive analysis of US regulatory activities related to prescription drugs is conducted and communicated to relevant stakeholders in Regulatory Affairs, Management and cross‑functionally as needed.

Leads the development of regulatory policy positions, written summaries, analyses and supporting materials relevant to the company’s programs and corporate objectives as assigned.

• Ensures leadership for Regulatory Policy in assigned areas, focusing on one or more following:
  • US regulations, policy and guidance issues impacting development of prescription drugs including, but not limited to:
    • Clinical trials
    • Marketing authorizations and periodic reporting
    • Rare Diseases, Orphan Drug and accelerated/innovative pathways
    • Pediatric drug development
    • Trends and activities related to US health authority regulation of prescription drugs
  • Attends/represents Regulatory Affairs at regulatory policy meetings with FDA, Industry, and other government agencies
  • Strengthens organization situational awareness and advance company regulatory policy priorities
  • Represents Neurocrine Biosciences/Regulatory Affairs interests within trade associations, other formal and/or informal coalitions and FDA/Health Authority working groups
  • Establishes partnerships within Regulatory Affairs and QRAMP, and with Neurocrine Biosciences stakeholders, such as Public Policy, Government Affairs, Patient Advocacy, Corporate Affairs, Clinical Development, Research, Legal, Medical Affairs, and Commercial to help identify and translate Regulatory Affairs’ policy and program priorities into timely and effective strategies and materials to help shape policy outcomes within federal and state agencies and trade associations
  • Leads development of regulatory policy analyses for matters impacting the company, including the assessment of US legislative and regulatory proposals. Oversees development of regulatory policy positions and supporting materials necessary to respond to such proposals
  • Manages the development of quantitative and qualitative analysis, in partnership with internal and external teams to evaluate the implications of, and/or impacts to the company of relevant US regulatory proposals, with an emphasis on drug development pathways, innovative regulatory/dev­el­op­ment pathways, pediatric and rare disease development
  • Oversees internal and external regulatory advocacy efforts, and the development and dissemination of compelling communication materials
  • Proactively monitors Federal and state‑level regulatory landscape for potential issues with direct relevance to the company
  • Establishes frameworks and processes for impact assessments and summaries for revised/new US regulations, guidances and initiatives, and communicates/trains relevant internal audiences
  • Responsible for strategic planning, direction and goal setting for Regulatory Policy in collaboration with Regulatory management
  • Other duties as assigned

• Required:
  
  BS/BA degree in Regulatory Sciences, Business, Political Science, or related field AND 12+ years related work experience in Public Policy focused role OR Master’s Degree AND 10+ years of similar experience noted above

• In‑depth understanding of regulatory and industry issues; able to develop strategic recommendations and impact assessments
• Broad expertise or unique knowledge in regulatory policy matters
• Considered a leader and expert within the company
• Established external presence in regulatory policy
• Expertise in relevant discipline with broad knowledge of closely related areas, such as public policy, federal/government and corporate affairs
• Lead multiple departmental and cross‑functional initiatives
• Good leadership, mentoring skills
• Excellen…