Senior Regulatory Policy Director

Role Overview

• 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