Director, Regulatory Affairs, Ad Promo & Labeling

Role Summary

Director, Regulatory Affairs, Ad Promo & Labeling

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’s 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

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

Skills

• Regulatory strategy and operations
• Promotional review and labeling compliance
• FDA and health authority regulatory landscape
• Cross-functional collaboration with Medical, Legal, and Commercial teams
• Communication and leadership in a fast-paced, small-team biotech environment

Education

• Bachelor’s degree in life sciences or related field

Additional Requirements

• Location: Office locations in Rockville, Maryland, and Redwood City, California (if applicable in description)