Senior Regulatory Affairs Specialist
2 weeks ago
We are seeking a highly skilled Senior Regulatory Affairs Specialist to lead our advertising and promotion regulatory efforts. As a key member of our team, you will be responsible for ensuring compliance with FDA regulations and guidelines for commercial materials.
Key Responsibilities:
- Lead cross-functional collaboration to ensure timely reviews and submissions of commercial materials
- Develop and maintain business partnerships with internal stakeholders to enhance compliance and efficiency
- Assess and communicate potential risks and impacts to senior leadership
- Proactively identify and recommend process improvements to enhance compliance and efficiency
- Mentor and develop junior team members
Requirements:
- 10+ years of experience in Regulatory Affairs, including significant experience in advertising and promotion process management
- 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
About Neurocrine Biosciences
We are 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 various ways to meet our requirements.
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