Director, US Regulatory Advertising – Promotion

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the internal expert on FDA Advertising & Promotion matters for designated products.

• Offer regulatory guidance and solutions regarding promotional materials to ensure compliance with FDA regulations.

• Conduct regulatory training sessions covering FDA requirements, PhRMA DTC Guidelines, and company policies.

• Lead the Promotional Review Committees assigned to you and assist Medical Review Committees.

• Serve as the regulatory reviewer within copy approval teams.

• Create Standard Operating Procedures (SOPs) and work instructions to optimize workflows.

• Act as the company's liaison with OPDP/FDA concerning advertising and promotional issues.

• Oversee OPDP/APLB interactions, regulatory inquiries, advisory-comment submissions, and discussions with staff.

• Encourage collaboration between Regulatory and PRC partner functions.

• Provide commercial regulatory guidance to US Commercial Teams.

• Lead PRC teams in the compliant execution of marketing strategies and initiatives.

• Implement updated product labels, manage content lifecycle, and develop risk information and training materials.

⛳️ Requirements

• At least 8 years of experience in the pharmaceutical industry.

• A minimum of 6 years in regulatory affairs.

• In-depth knowledge of advertising promotion regulations and FDA Guidance documents.

• Technical expertise in drug development and labeling processes.

• Experience with promotional and medical review supporting product communications.

• Familiarity with FDA operations, particularly OPDP and APLB, regarding advertising and promotion issues.

• Capability to comprehend and interpret clinical trial data.

• Extensive understanding of FDA promotional regulations, product and therapeutic information, and evidentiary standards for product claims.

• Strong oral and written communication and negotiation abilities.

• High attention to detail.

• Skill in identifying issues, presenting product facts, and suggesting risk-mitigation strategies.

• Ability to communicate the effects of inadequate risk mitigation.

• Proficient in influencing and effectively interacting across various functions and with regulatory bodies.

• Understanding of commercial objectives and FDA compliance standards.

• Capacity to develop innovative ideas and best practices.

• Skill in anticipating and resolving issues.

• Leadership, teamwork, and cross-functional collaboration capabilities.

• Ability to manage multiple activities or projects simultaneously.

• Bachelor's degree in a scientific field.

• Proficient in English.

🏝️ Benefits

• Eligibility for short-term incentives program.

• Eligibility for long-term incentives program.

• Commitment to an inclusive and equal-opportunity workplace.

• Support for application adjustments available upon request.

• Investment in employees and transformative projects.