Regulatory Ad Promo Associate Director

Socket.dev; San Diego (CA); On-site; USD 174,000 - 238,000; Full time

Job summary

Neurocrine Biosciences in San Diego seeks a senior Regulatory Affairs professional to lead medical education and promotional material reviews, ensuring compliance with FDA advertising rules. You will partner with PRC, MRC, and field teams to shape strategy and drive timely submissions.

You will evaluate regulatory guidance, manage risk communications to Sr. Leadership, and help refine processes for efficiency and compliance across product campaigns.

Qualifications

• 10+ years of Regulatory Affairs experience in biotech/pharma or devices.
• Experience with Advertising & Promotional review processes per FDA guidelines.
• Ability to lead cross-functional teams and manage complex regulatory reviews.

Responsibilities

• Assumes leadership in the PRC Process to ensure compliance with FDA advertising and promotional regulations and guidelines for assigned products and materials.
• Responsible for timely and accurate review and submission of promotional materials (FDA 2253 submissions).
• Represents Regulatory Affairs on the Medical Review Committee and conducts regulatory review of materials for field use.
• Tracks FDA guidance and communicates risks to Sr. Leadership.
• Maintains SOPs and department practices; mentors junior staff.

Skills

Regulatory Affairs

Advertising & Promotion

FDA guidance

Cross-functional collaboration

Leadership

Education

BS/BA Life/Health Sciences

Master’s in Life/Health Science

Tools

Veeva Vault

Adobe Pro

Microsoft Office

Job description

Who We Are:

Neurocrine Biosciencesis 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 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:

Serves as the lead reviewer for medical education and commercial advertising and promotional materials for product, disease state, and training/education programs. Leads cross-functional collaboration to ensure appropriate reviews take place and timely submissions are made to OPDP. Work closely with the Director, Regulatory Ad Promo to formulate the strategic direction and develop process improvements for the Regulatory Ad/Promotion function.Proactively reviews regulatory promotional guidelines and untitled/warning letters; assesses phase IV clinical trial design with regard to possibilities for use in proactive or reactive marketing or medical communication. Assesses labeling changes for potential impact on Ad/Promo and and medical communications materials.

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Your Contributions (include, but are not limited to):

• 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

Requirements:

• 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

#LI-SA1

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 $173,900.00-$238,000.00. 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.