Associate Director, Global Regulatory Advertising and Promotion

Moderna Therapeutics; Cambridge (MA); On-site; USD 142,500 - 256,500; Full time

Benefits offered by this job

Competitive pay

Comprehensive benefits

In-office collaboration model

Job summary

Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure FDA and global promotional compliance across channels. You will serve as a liaison among Regulatory Affairs, Legal, Medical, and Commercial teams to align regulatory strategy with business goals.

The role requires 5+ years in regulatory affairs with a focus on advertising and promotion, experience with PMRT/MRC, and familiarity with EMA, Health Canada, and UK authorities.

Qualifications

• 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 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.
• Lead PMRT and MRC discussions with Marketing, Medical, Legal, and Compliance teams to develop compliant promotional material.
• Support interactions with FDA's Advertising and Promotional Labeling Branch (APLB) and other regulatory authorities; prepare regulatory submissions for promotional materials (e.g., 2253 filings).
• Develop and deliver training programs on promotional regulations for internal stakeholders; refine internal SOPs and review processes.
• Monitor enforcement actions and industry trends to mitigate regulatory risks.

Skills

Regulatory knowledge

Cross-functional collaboration

Global regulatory knowledge

Communications skills

Attention to detail

Education

Bachelor’s degree in Life Sciences/Regulatory Affairs

Advanced degree (PharmD/JD/Regulatory Affairs)

Job description

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. The ideal candidate will have expertise in FDA regulations, OPDP (Office of Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry best practices.

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.

Skills & Competencies

• Deep understanding of US and global regulatory frameworks for advertising and promotion.
• Excellent ability to interpret and apply regulatory guidelines and requirements in a business-focused, solutions-oriented manner.
• Strong written and verbal communication skills, with experience in preparing regulatory documentation.
• Ability to work cross-functionally and manage multiple projects in a fast-paced environment.
• Strong attention to detail and problem-solving skills.

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. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

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. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

As we build our company, we have always believed 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. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.