Senior Director, Regulatory Affairs, Advertising and Promotion (Manager)
Merck KGaA
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
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