Senior Regulatory Affairs Specialist

2 weeks ago


San Diego, California, United States Neurocrine Biosciences Full time
About the Role

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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