Neurocrine Biosciences
You Deserve Brave Science
Senior Regulatory Policy Director
Location
Washington
Posted
16 days ago
Salary
$242.3K - $330K / year
Bachelor Degree12 yrs expEnglish
Job Description
• 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
Job 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
