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The role of Associate Director, Regulatory Affairs Advertising & Promotion involves providing strategic regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products. This includes ensuring compliance with US laws and regulations, as well as company policies.

The successful candidate will be responsible for:

  • Providing subject matter expertise on FDA regulations and OPDP guidance governing promotion and prescription drug/biologic products and disease awareness activities.
  • Participating in multidisciplinary medical, legal, and regulatory review teams with individual responsibility for the review, risk assessment, and regulatory decisions regarding product communications.
  • Providing regulatory strategic oversight for complex products or therapeutic areas/multiple products to ensure regulatory compliance of promotional and non-promotional materials assigned, including management of Form 2253 submissions.
  • Maintaining up-to-date knowledge of the US regulatory promotional environment, including new FDA regulations/guidance documents, relevant FDA enforcement actions, and general awareness of industry practices.
Key Responsibilities
  • Serving as a subject matter expert on FDA regulations and OPDP guidance.
  • Leading multidisciplinary review teams.
  • Managing regulatory compliance for promotional and non-promotional materials.
  • Maintaining awareness of the US regulatory promotional environment.

The ideal candidate will have:

  • A bachelor's degree in science or health-related discipline (advanced degree preferred).
  • At least 6 years of relevant pharmaceutical industry experience.
  • 4+ years of relevant prescription product advertising and promotion review experience.