The RoleThe 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 & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.- 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
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.
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