Director, Regulatory Affairs, AD/Promo - Military veterans preferred

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.

• 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.