Neurocrine Biosciences

Senior Regulatory Policy Director

Neurocrine Biosciences

full-time

Posted on:

Location Type: Remote

Location: Washington • United States

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Salary

💰 $242,300 - $330,000 per year

Job Level

Senior

About the role

  • Leads the Regulatory Policy function responsible for proactively monitoring, analyzing and summarizing developments in regulations, guidance developments impacting pharmaceutical development for Neurocrine Bioscience’s products
  • Informs and influences policy matters with external stakeholders
  • Establishes partnerships with Neurocrine Bioscience’s 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 are conducted and communicated to relevant stakeholders
  • Leads the development of regulatory policy positions, written summaries, analyses and supporting materials relevant to the company’s programs and corporate objectives

Requirements

  • BS/BA degree 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
  • 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
  • Excellent interpersonal and influence skills
  • Excellent written and verbal communications, problem-solving, analytical thinking skills
  • Can strategically evaluate regulatory policy needs for the broader picture and longer-term impact on drug development and department/company, integrating analysis of regulatory impact with deep consideration of relevant issues and development of recommendations/solutions
  • Strong leadership, communication and interpersonal skills
  • Expertise working with US Regulators, and federal or state policy makers and agencies
  • Demonstrated expertise in understanding the workings of FDA and related US legislative bodies and administrative agencies
  • Track record of successfully leveraging participation in government-industry coalitions and trade association activities
  • Self-starter, highly skilled in verbal and written communications with demonstrated ability to convey - in a clear and compelling manner – strategies and impact to internal and external parties with different backgrounds and interests, from internal tactical teams and senior management to external trade groups and policy makers
  • Track record of working in a collaborative manner with a range of internal and external stakeholders with successful influence
  • Proven ability to build effective relationships with internal and external constituencies, including senior business leaders, regulatory officials, counterparts at other companies, and industry representatives
Benefits
  • Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
  • Retirement savings plan (with company match)
  • Paid vacation, holiday and personal days
  • Paid caregiver/parental and medical leave
  • Annual bonus with a target of 35% of the earned base salary
  • Eligibility to participate in equity based long term incentive program
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory policyimpact assessmentsstrategic recommendationsregulatory analysisFDA knowledgegovernment-industry coalitionstrade association activitiespublic policy expertisecross-functional initiativesregulatory impact evaluation
Soft Skills
leadershipmentoringinterpersonal skillsinfluence skillswritten communicationverbal communicationproblem-solvinganalytical thinkingcollaborationrelationship building
Certifications
BS/BA degree in Regulatory SciencesBS/BA degree in BusinessBS/BA degree in Political ScienceMaster's Degree in related field