Senior Manager – Global Regulatory – Advertising & Promotion
| Company | Moderna |
|---|---|
| Location | Cambridge, MA, USA, Princeton, NJ, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline).
- Minimum 2-4 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.
- 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.
Responsibilities
- Review and approve promotional materials, corporate communications, and disease awareness campaigns to ensure compliance with FDA and other applicable regulatory requirements.
- Help provide guidance on promotional considerations during early stages of product development.
- Maintain up-to-date knowledge of regulatory requirements, enforcement trends, and industry best practices.
- Act as a key member of 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.
- Support interactions with the FDA’s Advertising and Promotional Labeling Branch (APLB) and other regulatory authorities as needed.
- Assist in preparing 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.
Preferred Qualifications
- Advanced degree (PharmD, JD, or Master’s in Regulatory Affairs) preferred.
- Global regulatory knowledge (EMA, Health Canada, etc.) is a plus.
- Familiarity with digital and social media promotional compliance.
- Experience in infectious diseases, oncology, rare diseases, and/or vaccines is a plus.