Sr. Regulatory Policy Director

Neurocrine Biosciences

3d

About The Position

Leads the Regulatory Policy function that is responsible for proactively monitoring, analyzing and summarizing developments in regulations, guidance developments impacting pharmaceutical development for Neurocrine Bioscience’s products, pipeline and the patients we serve, primarily for the US. Informs and influences policy matters with external stakeholders, and 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 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.

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
• 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
• 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

Responsibilities

• 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

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director