Associate Director, Global Regulatory Advertising and Promotion

Moderna · Cambridge, MA · 1 mo ago

Marketing$143k–$257k/yrFull-time

The Role

The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements for promotional and non-promotional materials across various communication channels. This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic regulatory guidance on advertising and promotional activities.

Here's What You’ll Do

Regulatory Compliance & Review
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.
Cross-Functional Collaboration
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.
Health Authority Interactions
Support interactions with the FDA’s Advertising and Promotional Labeling Branch (APLB) and other regulatory authorities as needed.
Prepare regulatory submissions for promotional materials, including 2253 filings and advisory comments requests.
Address regulatory queries from health authorities regarding promotional and advertising content.
Training & Process Improvement
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.

Here’s What You’ll Need (Basic Qualifications)

Education
Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline). Advanced degree (PharmD, JD, or Master’s in Regulatory Affairs) preferred.
Experience
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.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

Familiarity with digital and social media promotional compliance
Experience in infectious diseases, oncology, rare diseases, and/or vaccines is a plus.

Pay & Benefits

The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.

Our Working Model
We believe an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.