Role Summary:
The Executive Director, Regulatory Affairs Advertising & Promotion leads regulatory strategy and compliance for advertising and promotional activities across all external communications. This role serves as the subject matter expert, partnering with the launch team, commercial, medical affairs, R&D, corporate communications, legal, and leadership to ensure messaging aligns with FDA regulations and company objectives.
The person in this role provides strategic guidance on complex promotional claims, anticipates market and regulatory factors, and drives innovative, compliant solutions. This role chairs the regulatory review for the Promotion Review Committee (PRC) and for the Medical Review Committee (MRC), balancing legal requirements with business goals while mitigating risk across promotional campaigns and corporate communications.
This role is based in Waltham, MA without the possibility of being a fully remote role.
Primary Responsibilities:
• Serves as the subject matter expert for Regulatory Affairs Ad/Promo, providing leadership and development of innovative and compliant strategies to support communication and promotional objectives. • Proactively identifies and evaluates fundamental issues, providing strategy and direction, anticipating factors that could influence strategies and company position in the market. • Leads the PRC to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance. • Serves as lead Regulatory Advertising & Promotion expert on MRC. • Accountable for review and approval of external communications materials for promotion and scientific exchange, and corporate messaging in line with relevant goals and deliverables with a broad impact on the organization. • When needed, delegates tasks effectively and appropriately to direct focus on strategic planning and execution. • Proposes creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize risk. • Supports Commercial launch teams, participating in strategy discussions and extended team meetings to provide regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. • Provides promotional regulatory input on concepts and draft materials to ensure they are aligned with promotional regulations, corporate standards and policies, and business objectives. • Leads the development and implementation of guidelines and processes for the creation, review, approval, and regulatory submission, where applicable, of external communications content. • Acts as the recognized authority on regulatory advertising and promotion matters. • Able to work independently and deal with division or corporate functions, or with external agencies. • Serves as primary Regulatory Advertising & Promotion contact for Regulatory Agencies. • Actively participates in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it related to the use of study results in US and global promotion. • Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters, and policies issues affecting the pharmaceutical/biologics industry and communicates significant changes in FDA perspective to relevant stakeholders. • Contributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review.
Education and Skills Requirements:
A BS degree in scientific, clinical, or related area is required. Advanced degree is highly desirable. 12+ years pharmaceutical/biotech industry experience with a minimum of 10 years of direct experience as primary Regulatory reviewer of advertising and promotional materials is required.
In-depth understanding of strategic regulatory advertising and promotion concepts as well as breadth of regulatory advertising & promotion expertise is successful. Launch experience, preferably including global product launches, is also required.
Key skills and qualifications include:
• Strong track record of implementing successful business strategies for branded and unbranded promotional campaigns. • Ability to see impact of decisions across various segments of the organization, including Medical Affairs and Corporate Communications activities. • Strong interpersonal skills and proven negotiator with demonstrated ability to use constructive debate to identify and move others towards compliant promotional outcomes. • Ability to communicate and influence without authority at all levels of the organization and externally. • Well organized with exceptional communication skills, strong influencing skills, strong technical writing and documentation skills, as well as strong analytical and problem-solving skills. • Thinks innovatively and creatively, identifying the risks surrounding promotional claims and campaigns. • Proficient in computer applications and configurations including Microsoft Office Suite or related software, Veeva PromoMats, and VeevaMedComm systems. • Demonstrated history of successful interactions with promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch. • Positive team member who embodies the Dyne Core Values. • Excitement about Dyne's vision and mission.