Senior Specialist, Regulatory Ad/Promo

A growing commercial-stage biotechnology company focused on advancing innovative therapies in oncology and immunology is seeking a Senior Specialist, Regulatory Affairs - Advertising & Promotion. This individual will play a key role in supporting promotional regulatory activities for marketed products, partnering closely with Commercial, Medical Affairs, and Legal teams to ensure promotional materials and strategies remain compliant while supporting business objectives. This is an excellent opportunity to join a collaborative and fast-paced environment where regulatory expertise directly impacts product success and patient outcomes.

Key Responsibilities:

• Review and provide regulatory guidance on U.S. promotional and advertising materials.
• Partner with Commercial, Medical, and Legal teams to ensure promotional activities remain compliant with FDA regulations.
• Support interactions and correspondence with FDA promotional review divisions (OPDP/APLB).
• Contribute to promotional regulatory strategies that balance business objectives with compliance requirements.
• Participate in promotional review committees and provide feedback on marketing concepts and campaign materials.
• Advise cross-functional teams on promotional regulations, risk assessment, and labeling considerations.
• Monitor evolving FDA guidance, enforcement trends, and industry best practices related to advertising and promotion.
• Communicate regulatory updates and potential impacts to internal stakeholders.
• Assist with SOP development, process improvements, and promotional review initiatives.
• Support additional regulatory and cross-functional projects as needed.

Qualifications:

• Bachelor's degree with 7+ years, Master's degree with 5+ years, or PhD/PharmD with 3+ years of relevant pharmaceutical, biotechnology, or regulatory experience.
• Minimum 3 years of direct experience reviewing pharmaceutical or biologic advertising and promotional materials.
• Strong understanding of FDA regulations governing prescription drug and biologic advertising and promotion.
• Experience interacting with FDA promotional review groups (OPDP/APLB) and/or supporting product launch strategies.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Demonstrated strategic thinking, attention to detail, and problem-solving abilities.
• Scientific background in pharmacology, immunology, oncology, or a related discipline preferred.