Senior Director, Regulatory Advertising and Promotion

 

Work Your Magic with us! Start your next chapter and join EMD Serono.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role

The Senior Director, Advertising and Promotion serves as the strategic regulatory leader for U.S. promotional activities across assigned products or portfolio, accountable for the oversight, governance, and direction of promotional review and approval processes. This role ensures enterprise-level compliance with applicable laws, regulations, and FDA guidance while shaping forward-looking promotional regulatory strategies. As a senior advisor, this individual provides authoritative guidance to cross-functional leadership and influences key business decisions.

 

Operating with significant autonomy, the Senior Director drives alignment, fosters a culture of compliance, and enables the development of innovative, compliant promotional strategies that advance organizational objectives.

 

Key Accountabilities:

• Provide cross-functional leadership and representation for Regulatory Affairs on Promotional Review Committees, ensuring U.S. promotional materials are compliant with regulatory requirements while shaping and aligning with overarching corporate and portfolio strategies.
• Serve as the senior strategic liaison to FDA promotional review divisions (OPDP and APLB), overseeing high-impact interactions, guiding complex regulatory negotiations, and ensuring consistency and quality in correspondence and advisory submissions.
• Define and shape innovative, compliant regulatory strategies and solutions for highly complex and business-critical promotional concepts, enabling enterprise objectives while proactively mitigating regulatory risk across the portfolio.
• Lead the oversight and evaluation and positioning of product claims for assets in development, ensuring scientifically robust, compliant messaging and guiding the development of Important Safety Information (ISI) and Brief Summary documents.
• Establish and advance the strategic framework for advertising and promotion processes, standards, and SOPs, driving continuous improvement, governance, and operational excellence across the organization.
• Lead enterprise interpretation of evolving regulatory trends, guidance, and enforcement activities, and proactively shape organizational strategy by advising senior Regulatory Affairs leadership, review committees, and cross-functional stakeholders on implications for business decisions and compliance.
• Identify and provide solutions during labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.
• Oversee and provide direction on regulatory communications, including responses to FDA action letters and high-visibility interactions with OPDP and APLB.
• Champion and oversee department-wide capability building, including the strategy, design, and execution of training programs to strengthen organizational expertise and compliance awareness in promotional regulations.
• Serve as a key strategic leader across the organization, influencing senior stakeholders across Marketing, Legal, Medical, and Regulatory functions to enable compliant, effective, and business-aligned promotional execution.
• Provide