Global Regulatory Ad & Promo Strategy Lead

RXinsider LTD.; Cambridge (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Equity/incentive potential

Job summary

Moderna seeks an Associate Director, Global Regulatory Advertising and Promotion to ensure compliance across promotional and non-promotional materials. You will liaise with Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic guidance on advertising activities.

You will lead reviews, train stakeholders, and interact with health authorities while staying current on global regulatory expectations and enforcement trends.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline.
• Advanced degree (PharmD, JD, or Master’s in Regulatory Affairs) preferred.
• Minimum 5 years of experience in Regulatory Affairs, with at least 2 years focused on advertising and promotion in the pharmaceutical, biotech, or medical device industry.
• Strong knowledge of applicable regulations and enforcement trends
• Prior experience working with cross-functional review committees in a regulated environment.
• Global regulatory knowledge (EMA, Health Canada, UK etc.) is a plus.

Responsibilities

• Review and approve promotional materials, corporate communications, and disease awareness campaigns to ensure compliance with FDA and other applicable regulatory requirements.
• Guide promotional strategy as the Regulatory Ad Promo representative during early stages of product development
• Maintain up-to-date knowledge of regulatory requirements, enforcement trends, and industry best practices.
• Lead discussions for assigned products during the Promotional Material Review Team (PMRT) and Medical Review Committee (MRC) working closely with Marketing, Medical, Legal, and Compliance teams to develop impactful material that aligns with regulatory expectations.
• Prepare regulatory submissions for promotional materials, including 2253 filings and advisory comments requests.
• Address regulatory queries from health authorities regarding promotional and advertising content.
• Develop and deliver training programs on promotional regulations for internal stakeholders.
• Help refine internal SOPs, best practices, and review processes for advertising and promotion compliance.
• Monitor and analyze enforcement actions and industry trends to proactively mitigate regulatory risks.

Skills

Regulatory compliance

FDA advertising

Global regulatory

Cross-functional collaboration

Regulatory documentation

Written/verbal communication

Education

Bachelor’s degree in Life Sciences/Regulatory Affairs

Advanced degree (PharmD/JD/Regulatory Affairs)

Job description

Moderna seeks an Associate Director, Global Regulatory Advertising and Promotion to ensure compliance across promotional and non-promotional materials. You will liaise with Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic guidance on advertising activities.

You will lead reviews, train stakeholders, and interact with health authorities while staying current on global regulatory expectations and enforcement trends.