Director, Regulatory Affairs, Ad Promo & Labeling

Role Summary

Director, Regulatory Affairs, Ad Promo & Labeling responsible for leading regulatory oversight of advertising, promotion and labeling strategies for our products, including interactions with FDA and internal cross-functional teams. You will develop labeling strategies, review materials, and ensure compliance for promotional campaigns as we prepare for first product launch.

Responsibilities

• Serve as the lead Regulatory representative on the Promotional Review and Medical Review Committees
• Independently review and approve promotional/non-promotional materials
• Ensure regulatory compliance with the current labeling, applicable regulations, guidance documents, and internal policies/best practices
• Collaborate with Medical, Legal and Commercial to execute and approve key Commercial campaigns
• Monitor evolving FDA regulations, enforcement actions, and industry best practices; translate insights into internal training and process improvements
• Develop and implement labeling strategies, including creation, review, and maintenance of prescribing information, patient information, and packaging components
• Serve as primary liaison with FDA‚Äôs Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) on ad promo submissions, inquiries, and regulatory correspondence
• Contribute to broader regulatory strategy and operations as a key leader within a small, agile team preparing for its first product launch

Qualifications

• Required: Bachelor‚Äôs degree in life sciences or related field
• Required: 10+ years of regulatory affairs experience in the biopharmaceutical industry, with significant expertise in advertising, promotion, and labeling
• Required: In-depth understanding of FDA regulations and guidelines, and other relevant health authority requirements for pharmaceuticals
• Required: Ability to apply regulatory knowledge to develop practical solutions and strategies for complex promotional and labeling issues
• Required: Proven track record of supporting pre-launch through commercial stages, ideally in oncology or specialty pharmaceuticals
• Required: Ability to operate strategically while managing hands-on responsibilities in a small, fast-paced biotech environment
• Required: Strong leadership, verbal/written communication, and collaboration skills with the ability to influence internal/external stakeholders
• Required: High level of integrity and commitment to regulatory compliance in support of patients and healthcare providers

Education

• Bachelor‚Äôs degree in life sciences or related field