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Moderna

Develops mRNA-based medicines for health

Associate Director, Global Regulatory Advertising and Promotion

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in a relevant field, such as Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline.
  • At least 5 years of experience in Regulatory Affairs, including 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.
  • A deep understanding of U.S. and global regulatory frameworks for advertising and promotion.
  • Ability to interpret and apply regulatory guidelines and requirements in a business-focused, solutions-oriented manner.
  • Strong written and verbal communication skills, with experience 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.
  • Only individuals qualifying as U.S. persons—citizens, permanent residents, asylees, or refugees—are eligible because the position may involve access to export-controlled information.

Responsibilities

  • Review and approve promotional materials, corporate communications, and disease awareness campaigns for compliance with FDA and other applicable regulatory requirements.
  • Guide promotional strategy as the Regulatory Advertising and Promotion representative during early stages of product development.
  • Maintain current knowledge of regulatory requirements, enforcement trends, and industry best practices.
  • Lead discussions for assigned products during the Promotional Material Review Team and Medical Review Committee, working with Marketing, Medical, Legal, and Compliance teams to develop materials aligned with regulatory expectations.
  • Support interactions with the FDA's Advertising and Promotional Labeling Branch 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.
  • Develop and deliver training programs on promotional regulations for internal stakeholders.
  • Help refine internal standard operating procedures, best practices, and review processes for advertising and promotion compliance.
  • Monitor and analyze enforcement actions and industry trends to proactively mitigate regulatory risks.

Desired Qualifications

  • An advanced degree such as a PharmD, JD, or Master's in Regulatory Affairs.
  • Global regulatory knowledge, including EMA, Health Canada, and UK frameworks.
  • Familiarity with digital and social media promotional compliance.
  • Experience in infectious diseases, oncology, rare diseases, and/or vaccines.

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

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