Director, Regulatory Affairs, AD/Promo

4 weeks ago

Pittsburgh, United States Attaineo Search, Inc. Full time
Job Description
Position: Director of Regulatory Affairs, Advertising/Promotions (AD/Promo)

Location: Pittsburgh, Pennsylvania (Remote)

Overview: This role involves leading advertising and promotion activities, ensuring they comply with U.S. regulations. The ideal candidate should be proactive, able to work independently, have strong organizational skills, and have a deep understanding of the FDA regulatory environment.

Key Responsibilities:

  • Lead and supervise advertising and promotion activities, focusing on regulatory concerns.
  • Provide expertise on U.S. regulations for advertising and promotion of prescription products, especially in commercial and medical affairs.
  • Serve as the go-to expert on Regulatory AdPromo, solving issues related to product launch materials and strategies.
  • Improve efficiency in the Advertising and promotion process.
  • Communicate directly with the OPDP regarding advertising and promotional materials.
  • Build and maintain strong relationships with internal stakeholders to develop AdProm strategies.
  • Review marketing materials for compliance with regulations.
  • Help develop and update prescribing information.
  • Train stakeholders on advertising and promotion regulations.
  • Stay updated on FDA regulations and guidance and uphold company values.
Requirements
  • Bachelor's degree (or equivalent) in a scientific discipline; an advanced degree is a plus.
  • Minimum of 5 years of experience in Regulatory Affairs with expertise in AdPromo
  • Deep knowledge of regulatory guidance for advertising and promotion of pharmaceutical products and understanding of the FDA
  • Strong analytical, communication, interpersonal, and project management skills
  • Proficient in Microsoft Office Suite
  • Able to work independently and carry out supervisory responsibilities.

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