Senior Manager, Global Regulatory, Advertising & Promotion

Moderna; Cambridge (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Manager for Global Regulatory Advertising and Promotion. This role involves ensuring compliance with regulatory standards for promotional materials and acting as a liaison among various teams. The ideal candidate will possess strong knowledge of FDA regulations and experience in regulatory affairs, particularly in advertising and promotion. Join a forward-thinking company that values innovation and collaboration, where you can make a significant impact on global health through mRNA technology. This position offers a dynamic work environment and comprehensive benefits to support your well-being.

Benefits

Healthcare

Mental Health Resources

Generous Time Off

Family Benefits

Qualifications

• 2-4 years in Regulatory Affairs with a focus on advertising and promotion.
• Strong knowledge of FDA regulations and enforcement trends.

Responsibilities

• Review and approve promotional materials for compliance with FDA regulations.
• Provide guidance on promotional considerations during product development.

Skills

Regulatory Affairs

FDA Regulations

Advertising Compliance

Cross-Functional Collaboration

Communication Skills

Problem-Solving Skills

Education

Bachelor’s degree in Life Sciences

Advanced degree (PharmD, JD, Master’s)

Job description

Senior Manager, Global Regulatory, Advertising & Promotion

Join to apply for the Senior Manager, Global Regulatory, Advertising & Promotion role at Moderna.

Role Overview

The Senior Manager, Global Regulatory Advertising and Promotion will ensure compliance with regulatory standards for promotional and non-promotional materials across communication channels. This role acts as a liaison between Regulatory Affairs, Legal, Medical, and Commercial teams, providing strategic guidance on advertising and promotional activities. Expertise in FDA regulations, OPDP (Office of Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry best practices is essential.

Key Responsibilities

• Review and approve promotional materials, corporate communications, and disease awareness campaigns for compliance with FDA and other regulatory requirements.
• Provide guidance on promotional considerations during early product development stages.
• Maintain current knowledge of regulatory requirements, enforcement trends, and industry best practices.
• Participate in the Promotional Material Review Team (PMRT) and Medical Review Committee (MRC), collaborating with Marketing, Medical, Legal, and Compliance teams to develop compliant and impactful materials.
• Support interactions with FDA’s Advertising and Promotional Labeling Branch (APLB) and other authorities.
• Assist in preparing regulatory submissions for promotional materials, including 2253 filings and advisory comments.
• Address regulatory queries from health authorities regarding promotional content.
• Develop and deliver training on promotional regulations for internal teams.
• Refine SOPs, review processes, and best practices for advertising and promotion compliance.
• Monitor enforcement actions and industry trends to mitigate regulatory risks proactively.

Basic Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• Optional: Advanced degree such as PharmD, JD, or Master’s in Regulatory Affairs.
• 2-4 years in Regulatory Affairs, with at least 2 years focused on advertising and promotion in pharma, biotech, or medical devices.
• Strong knowledge of applicable regulations and enforcement trends.
• Experience with cross-functional review committees in regulated environments.
• Global regulatory knowledge (EMA, Health Canada, etc.) is advantageous.
• Deep understanding of US and international regulatory frameworks for advertising and promotion.
• Excellent interpretation and application of regulatory guidelines.
• Strong communication skills, with regulatory documentation experience.
• Ability to manage multiple projects in a fast-paced setting.
• Attention to detail and problem-solving skills.

Preferred Qualifications

• Familiarity with digital and social media promotional compliance.
• Experience in infectious diseases, oncology, rare diseases, or vaccines.
• Motivation to contribute to a high-growth, innovative company with values of being Bold, Relentless, Curious, and Collaborative.

At Moderna, we support your well-being through comprehensive benefits, including healthcare, mental health resources, lifestyle accounts, family benefits, generous time off, and more. We foster a culture of inclusion, innovation, and impact.

Founded in 2010, Moderna is committed to transforming medicine with mRNA technology, fostering a collaborative and inclusive environment, and making a meaningful difference in global health.

We are an equal opportunity employer and support reasonable accommodations for applicants with disabilities. For accommodations, contact [e-mail].