Executive Director, Labeling, Advertising and Promotion - Regulatory Affairs

The Role: The Head of Regulatory Labeling and Advertising and Promotion will lead Moderna’s labeling and advertising/promotion functions globally, establishing robust, compliant processes to support an expanding product portfolio across therapeutic areas. This role is responsible for regulatory strategy, submission, and compliance in both labeling and AdPromo, ensuring consistency across products and seamless integration across the product lifecycle. As the team leader, this role will provide direction for the development, revision, and submission of labeling and promotional materials to regulatory bodies, including the FDA, and oversee global AdPromo practices to ensure adherence to international standards.

Here’s What You’ll Do: Leadership & Strategy: Define and execute the vision and mission for the Global Labeling and AdPromo functions in alignment with Moderna’s regulatory and commercial goals. Lead a cross-functional team to develop and implement end-to-end labeling and AdPromo processes that align with regulatory requirements and optimize operational efficiency. Oversee the creation, update, and submission of the Company Core Data Sheet (CCDS), prescribing information, and labeling artwork. Establish consistent labeling strategies and oversee the development of Target Label Profiles that support clinical development phases (Phases 1-4) and product launch readiness. Act as the subject matter expert on US and global labeling requirements, ensuring products comply with Health Agency guidelines, including the FDA, EMA, and other relevant authorities. Guide promotional strategy, ensuring compliance with FDA regulations, CFR, PhRMA Principles, and international standards for advertising and promotional materials.

Labeling Responsibilities: Lead the end-to-end labeling process for all products, including development, submission, and maintenance of labeling for global markets. Serve as Chair of the Global Labeling Team (GLT), ensuring collaboration with cross-functional partners to develop and approve the CCDS and updated labeling content. Oversee regulatory submission of labeling materials and updates, ensuring compliance with regional requirements and maintaining consistency across products. Provide guidance on clinical trial design to enable desired product claims and oversee regulatory labeling reviews for submissions across different regions.

Advertising and Promotion (AdPromo) Responsibilities: Direct the regulatory review of promotional and external communications, including media and scientific information, ensuring materials meet FDA and international regulatory requirements. Lead complex submission coordination with APLB, collaborating with cross-functional teams to ensure compliant and timely promotional activities. Partner with cross-functional teams to develop and execute new promotional initiatives, including speaker events, market research, and product sampling. Oversee the preparation and submission of press releases and promotional materials for regulatory review, maintaining awareness of evolving FDA and international promotional regulations.

Management & Stakeholder Engagement: Provide strategic leadership and development for the Labeling and AdPromo teams, fostering growth and accountability within the function. Collaborate closely with Regulatory Affairs, Commercial, Legal, and Medical Affairs teams to align promotional activities with regulatory compliance and business goals. Maintain engagement with regulatory authorities and industry stakeholders to keep abreast of emerging trends, regulatory updates, and industry best practices. Represent the labeling and AdPromo functions in discussions with senior management, external departments, and global regulatory agencies. Participate in forecasting and planning activities for resources for the Regulatory Affairs group for the future needs for GRS.

Here’s What You’ll Bring to the Table: Bachelor’s degree required; advanced degree (e.g., MS, PhD, PharmD) preferred. 15+ years of experience in the pharmaceutical/biotech industry with at least 8 years in Regulatory Affairs, with specialized experience in labeling and advertising/promotion. Proven leadership experience managing regulatory teams, including end-to-end labeling and AdPromo functions. Solid project management skills, and deep understanding of Digital ecosystem including AI/ML. Extended knowledge of science and data of assigned products and how that translates into labeling language. Extended knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion. Experience of product launch preferred. Demonstrated expertise in technology systems utilized for electronic documentation, including, but not limited to Microsoft Office, Adobe Acrobat, and Veeva. Ad/Promo experience in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.

Integrity:

overriding commitment to integrity and high standards in self and others. Achievement or Result Orientation:

a concern for working well or for surpassing a standard of excellence. Strategic orientation:

ability to link visions and daily work. Communication:

ability and intend to effectively explain, describe or convey information to a variety of audiences. Develops others:

involved in a genuine intent to foster development of others; mentoring. Flexibility/adaptability:

ability to adapt to and work effectively within a variety of situations and with various individuals or groups.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. #J-18808-Ljbffr