Senior Director Regulatory Affairs, US 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 manages a team of promotional regulatory professionals in the review and approval of U.S. promotional materials, ensuring high-quality and compliant execution.  Demonstrates strong promotional regulatory expertise and provides strategic input to support promotional review activities for prescription drug products.

 

Ensures all promotional materials comply with applicable laws, regulations, and regulatory agency guidance, including FDA requirements, and supports the development of compliant and effective promotional strategies.

 

Provides oversight and guidance across multiple therapeutic areas, with the ability to assess and make sound regulatory decisions on complex promotional regulatory issues. Drives alignment and facilitates effective collaboration with U.S. Marketing leadership to support business objectives while maintaining regulatory compliance.

 

Key Accountabilities:

• Build, lead, and mentor a high-performing U.S. regulatory Ad/Promo team.
• Shape and advance regulatory strategy and solutions governing U.S. advertising and promotion to enable sustained compliance with evolving regulatory requirements and alignment with Company policy and business priorities
• Manage interactions and correspondence with FDA’s promotional review divisions (OPDP and APLB), including addressing complex questions and overseeing submissions for advisory comment.
• Shape regulatory strategy and provide expert oversight on proposed product claims for assets in development, ensuring scientifically sound and compliant messaging, and guiding (or oversees) the development of Important Safety Information (ISI) and Brief Summary documents, as appropriate.
• Establish and advance the strategic framework for advertising and promotion processes and SOPs, driving continuous improvement to enhance operational efficiency and ensure sustained regulatory compliance
• Provide strategic leadership in monitoring and interpreting regulatory developments, guidance, and enforcement trends, and ensure timely dissemination of actionable insights to Regulatory Affairs teams, review committees, and cross-functional partners to inform compliant business decisions.
• Lead the evaluation of emerging regulatory trends, guidance, and enforcement activities, and proactively shapes organizational understanding by advising Regulatory Affairs, review leadership, and cross-functional stakeholders on regulatory and policy implications within OPDP and APLB, and the broader regulatory landscape to support informed, compliant decision-making.
• Drive strategic integration between labeling and promotional regulatory activities by partnering with the Regulatory Affairs labeling group to assess the impact of package insert changes on product promotion and overall communication strategy.
• Negotiate and influence business unit decisions by driving consensus with review and commercial leadership.
• Oversee and supports the execution of company-wide training on regulatory requirements for product promotion, ensuring ongoing skills development and compliance awareness across the organization. Perform additional responsibilities as needed.
• Provide strategic regulatory leadership as a core member of cross-functional promotional review teams, influencing key stakeholders across marketing, legal, medical, and regulatory functions to achieve compliant and business-aligned promotional outcomes.
• Drive the development and evolution of advertising and promotion processes and procedures, shaping best practices and governance to support compliant and effective promotional activities across the organization.
• Lead cross-functional collaboration with Quality on internal audits and CAPA activities, ensuring regulatory alignment and driving effective resolution of compliance findings.

Who You Are

Minimum Qualifications:

• Bachelor’s degree in science or health related discipline.  Advanced degree (PhD, MD, MS, PharmD) highly preferred.
• Minimum 10 or more years of pharmaceutical industry or related experience with an emphasis in regulatory or scientific disciplines, with a minimum of seven years of direct experience as the primary reviewer of advertising and promotional materials.
• Ability to provide supervision and support across multiple therapeutic areas.
• Demonstrated ability to make day-to-day regulatory decisions for escalations. 
• Demonstrated in-depth expertise in FDA regulations governing promotion development, implementation, and promotional review processes, with the ability to shape organizational interpretation and application.
• Comprehensive understanding of the clinical development lifecycle, regulatory policy, labeling strategy, and FDA approval processes, applied to inform and guide cross-functional strategic decisions.
• Proven ability to lead and resolve highly complex promotional regulatory challenges, driving innovative, compliant solutions across products and therapeutic areas.
• Exceptional diplomacy, influence, and negotiation skills, recognized for building consensus and effectively engaging senior stakeholders; demonstrated strategic and analytical leadership in shaping business and regulatory outcomes.

Preferred Qualifications:

• Experience supporting or leading drug promotion activities and product launches, with a solid understanding of commercialization and regulatory considerations across the product lifecycle.
• Comprehensive understanding of the pharmaceutical Regulatory Affairs landscape, including prescription drug promotion and labeling requirements.
• Demonstrated ability to lead and foster a culture of continuous learning, operational excellence, and process improvement within a matrixed organization.

 

Location: Boston, MA, USA (Seaport); Hybrid 3 days per week in office

 

Travel: <20%; International and Domestic

 

Pay range for this position: $258,300.00 - $387,500.00

 

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

 

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!