Regulatory Ad Promo Associate Director

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• Assumes a leadership role in the PRC Process for assigned products to ensure compliance with FDA advertising and promotional regulations and guidelines for select product, disease state, and all medical education materials

• Responsible for timely and accurate review, and timely submission of promotional materials (i.e. FDA 2253 submissions)

• Independently represents Regulatory Affairs on the Medical Review Committee (MRC) and be responsible for conducting the regulatory review of materials for assigned products/programs intended for use by the field medical team

• Track and evaluate FDA guidance, policies and the overall regulatory environment and must be able to assess and communicate potential risk and impact to Sr. Leadership

• Develop and maintain a business partnership environment between Regulatory Affairs, PRC and MRC partner functions in the review and approval of advertising and promotional materials

• Actively manages communications to Regulatory management, and ensures promotional claims are in compliance with terms of approved product registrations, current labeling, applicable laws, internal policies and external regulations

• Proactively assesses advertising and promotion-related processes and procedures to enhance efficiencies and compliance

• Identify and recommend/implement policy and/or process changes as needed in partnership with Director, Regulatory Ad/Promo

• Maintain standard operating procedures and department working practices

• Mentors and develops junior level team members

• Other duties as assigned

• BS/BA degree in Life/Health Sciences or related field and 10+ year's of Regulatory Affairs experience at a biotech, pharmaceutical or device company, including significant experience in Advertising & Promotion process management OR

• Master's degree in Life/Health Science or related field and 8+ years of similar experience as noted above

• Emerging as an internal thought leader with technical and/or business expertise

• Applies in-depth knowledge of own area of expertise to solve problems, with guidance from Director, Regulatory Ad/Promo on complex/high risk matters

• Applies expertise to manage critical projects and/or relationships

• Integrates analysis of business objectives and strategic direction to resolve problems and recommend solutions

• Has input into short-term strategy and may be involved in long-term strategy on a functional level

• Strong communications, problem-solving, analytical thinking, influencing skills

• Demonstrated ability to work independently with minimal direction, including functional representation within teams and committees in order to attain group goals

• Proven track record and experience in Advertising & Promotional review committees with a thorough understanding of FDA guidance and regulations

• Extensive knowledge of electronic document management systems (e.g. Veeva Vault or similar)

• Advanced in Microsoft Office programs and Adobe Professional.

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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