Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)
About the Role:Responsible for leading the regulatory review of medical education and commercial advertising and promotional materials for product, disease state, and training/education programs. Leads the Promotional Review Committee (PRC) process for assigned products and independently reviews materials as a subject matter expert to ensure compliance with FDA regulations, guidance, and internal policies. Works closely with cross-functional teams to support compliant and effective promotional strategies, assess regulatory risk, and ensure timely submissions to FDA.
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Your Contributions (include, but are not limited to):Leads the PRC process for assigned products to ensure compliance with FDA advertising and promotional regulations and guidelines for promotional, disease state, and medical education materials
Represents Regulatory Affairs on the Medical Review Committee (MRC) and conducts regulatory review of materials intended for use by field medical teams
Independently reviews advertising and promotional materials and provides clear, risk-based regulatory guidance by integrating scientific, regulatory, and business considerations
Responsible for timely and accurate review and submission of promotional materials, including FDA Form 2253 submissions
Evaluates FDA guidance, policies, enforcement trends, and the overall regulatory environment to assess and communicate potential regulatory risk and impact
Fosters strong cross-functional partnerships between Regulatory Affairs and PRC partner functions to support compliant and effective promotional review and approval processes
Ensures communications and promotional claims comply with approved product labeling, applicable laws, internal policies, and external regulations
Navigates complex cross-functional discussions and operates independently while appropriately seeking strategic alignment on highly complex, novel, or high-risk issues
Continually assesses advertising and promotion-related processes and procedures to enhance efficiency, consistency, and compliance and recommends or implements improvements as appropriate
Maintains standard operating procedures and department working practices
May mentor and develop more junior team members
Other duties as assigned
BS/BA degree in Life/Health Sciences or related field AND 8+ 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 6+ years of similar experience noted above
Anticipates business and industry issues; recommends relevant process / technical / service improvements
Demonstrates broad expertise or unique regulatory knowledge about advertising and promotion
Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
Ability to work as part of and lead multiple teams
Good leadership, mentoring skills and abilities; typically leads lower levels and/or teams
Excellent computer skills
Excellent communication, problem-solving, analytical thinking skills
Sees broader picture and longer-term impact on the organization
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management and strong project leadership skills
Exhibits strong organizational skills and high attention to detail.
Possesses excellent interpersonal skills and can work effectively with a variety of personnel from different functional disciplines
Ability to work independently with minimal direction, including functional representation within teams and committees to attain group goals
Proven track record and experience in Advertising & Promotional review committees with a thorough understanding of FDA guidance and regulations
Strong knowledge of electronic document management systems (e.g. Veeva Vault or similar)
Proficiency in Microsoft Office programs and Adobe Professional
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Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, 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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The annual base salary we reasonably expect to pay is $158,100.00-$216,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.Skills Required
- BS/BA degree in Life/Health Sciences or related field and 8+ years of Regulatory Affairs experience
- Master's degree in Life/Health Science or related field and 6+ years of similar experience
- Significant experience in Advertising & Promotion process management
- Strong knowledge of electronic document management systems (e.g. Veeva Vault or similar)
- Proficiency in Microsoft Office programs and Adobe Professional
Neurocrine Biosciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Neurocrine Biosciences and has not been reviewed or approved by Neurocrine Biosciences.
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Strong & Reliable Incentives — Total rewards commonly include sizable annual bonuses and RSUs that are characterized as generous. Pay packages are portrayed as robust when combining base, bonus, and equity.
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Healthcare Strength — Medical, dental, and vision coverage begin on the first day with multiple plan options and telehealth access. Health insurance quality is highlighted alongside overall compensation.
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Parental & Family Support — Paid parental and caregiver leave are offered for extended periods in addition to dedicated sick time. Family-building resources and new‑parent support are positioned as part of the core Total Rewards.
Neurocrine Biosciences Insights
What We Do
Neurocrine Biosciences is a 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, Parkinson’s disease, endometriosis* and uterine fibroids* , as well as clinical programs in multiple 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. Review our Community Guidelines: https://bit.ly/3L8M8hx *in collaboration with AbbVie
