Regulatory Affairs Director
5 days ago
We are seeking a highly skilled Regulatory Affairs Director to lead our Advertising and Promotion team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with FDA regulations and guidelines for our promotional materials.
Key Responsibilities- Lead the review and approval of promotional materials, including advertising and medical education content
- Collaborate with cross-functional teams to ensure timely and accurate submissions to the FDA
- Develop and maintain a thorough understanding of FDA guidance and regulations
- Assess and communicate potential risks and impacts to senior leadership
- Develop and maintain business partnerships with Regulatory Affairs, PRC, and MRC partner functions
- Actively manage communications to Regulatory management and ensure promotional claims are in compliance with approved product registrations, current labeling, and applicable laws
- Proactively assess and enhance advertising and promotion-related processes and procedures to ensure compliance and efficiency
- BS/BA degree in Life/Health Sciences or related field and 10+ years of Regulatory Affairs experience at a biotech, pharmaceutical, or device company
- Master's degree in Life/Health Science or related field and 8+ years of similar experience
- Emerging as an internal thought leader with technical and/or business expertise
- Strong communications, problem-solving, analytical thinking, and influencing skills
- 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
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. We are committed to building a diverse, equitable, and inclusive workplace and recognize that there are a variety of ways to meet our requirements.
We offer a competitive annual base salary of $167,000.00-$241,925.00, 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 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.
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