Responsibilities

• The Director, Advertising and Promotion serves as the U.S. promotional regulatory lead for assigned products and is accountable for the review, approval, and strategic oversight of promotional materials.
• The Director ensures compliance with applicable laws, regulations, and FDA guidance while providing independent, expert regulatory counsel to cross-functional stakeholders.
• Operating with a high degree of autonomy, the Director enables the development of compliant and effective promotional strategies that support business objectives and drive organizational success.
• The Director leads and represents Regulatory Affairs on Promotional Review Committees, ensuring that U.S. promotional materials for prescription products meet regulatory requirements and align with company strategy.
• As the primary regulatory liaison to FDA promotional review divisions, including OPDP and APLB, the Director manages correspondence, addresses complex regulatory inquiries, and oversees submissions for advisory comment.
• The role requires the ability to propose innovative and compliant regulatory strategies and solutions to complex promotional concepts, balancing business objectives with regulatory risk.
• The Director leads the strategic evaluation and regulatory positioning of proposed product claims for assets in development, including oversight of Important Safety Information (ISI) and Brief Summary documents, as appropriate.
• The role drives the development, implementation, and continuous improvement of advertising and promotion processes, standards, and standard operating procedures to enhance operational efficiency and ensure sustained regulatory compliance.
• The Director also leads the assessment of evolving regulatory trends, guidance, and enforcement activities, proactively advising Regulatory Affairs teams, review committees, and cross-functional stakeholders to inform business decisions and ensure compliance.
• The Director actively participates in labeling and global regulatory team discussions to ensure alignment of clinical development and labeling strategies with anticipated promotional claims and messaging.

Requirements

• Bachelor’s degree in a science or health-related discipline; advanced degree (PhD, MD, MS, or PharmD) strongly preferred.
• Minimum 8+ years of pharmaceutical industry or related experience, with a minimum of 5 years as a primary reviewer of advertising and promotional materials.
• In-depth knowledge of FDA regulations governing the development, review, and approval of prescription drug promotional materials, including OPDP and APLB processes.
• Demonstrated ability to identify and deliver solutions to complex promotional regulatory challenges, balancing business objectives with regulatory risk.
• Strong diplomacy, interpersonal, and negotiation skills, with a track record as a consensus builder across cross-functional teams.

Preferred

• Experience leading or supporting drug promotion activities and product launches within a pharmaceutical or biopharmaceutical environment.
• Comprehensive understanding of the Regulatory Affairs landscape for prescription drugs, including labeling strategy and clinical development alignment.
• Demonstrated ability to lead enterprise-wide training initiatives and foster a culture of continuous improvement and regulatory compliance.
• Excellent verbal and written communication skills, with the ability to translate complex regulatory concepts for diverse audiences.

Benefits

• Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .