Director, Global Regulatory and Scientific Policy

Emd Group; Washington (District of Columbia); On-site; USD 180,000 - 280,000; Full time

Job summary

EMD Serono seeks a Director of US Regulatory and Scientific Policy to shape the regulatory environment for innovative medicines and medical products. You will align science and policy, advising R&D, Regulatory Affairs, and senior leadership while engaging regulators and industry bodies.

Reporting to senior leadership, you will monitor policy trends, provide strategic insights to development programs, and help advance science-based regulatory frameworks that improve patient access and outcomes.

Qualifications

• Bachelor's degree in biological sciences, healthcare, public health, policy, regulatory affairs, legal studies or related discipline required; advanced degree preferred.
• 5+ years of experience in pharmaceutical, biotechnology, regulatory, policy, government, consulting, or related fields.
• Strong knowledge of drug development and the regulatory environment governing pharmaceuticals and biologics.
• Understanding of FDA regulations, guidance development processes, and international regulatory frameworks, including ICH.

Responsibilities

• Monitor evolving regulatory, legislative, scientific, and healthcare policy developments impacting the company and drug development ecosystem.
• Provide strategic policy analysis and actionable recommendations to product teams, regulatory leaders, R&D stakeholders, and senior management.
• Advise development teams on regulatory opportunities, emerging pathways, policy risks, and innovative approaches to accelerate development and patient access.
• Identify and help shape policy frameworks supporting innovation in regulatory science, clinical development, digital health, AI, rare diseases, and other topics.
• Represent the company in interactions with trade associations, policy organizations, and external stakeholders.
• Develop and advance company positions on regulatory and legislative issues, coordinating responses to guidance documents and information requests.
• Develop briefing materials, policy analyses, presentations, executive communications, and training content for internal stakeholders.
• Serve as internal SME in strategic policy areas and foster cross-functional collaboration across Regulatory Affairs, Clinical Development, Medical Affairs, CMC, Legal, Government Affairs, and other functions.
• Build strong internal and external relationships, lead through influence, and foster curiosity, innovation, continuous learning, and excellence.

Skills

Analytical thinking

Strategic thinking

Communication

Problem solving

Education

Bachelor's degree in biological sciences, healthcare, public health, policy, regulatory affairs, legal studies

Advanced degree (MS, PharmD, PhD, MD, MPH, JD, or equivalent)

Job description

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.

Why Join Us?

Shape the Future of Drug Development and Regulatory Policy.

This role offers the opportunity to help shape the future regulatory landscape for innovative medicines and medical products. You will work with internal and external leaders to advance policies that support scientific innovation, regulatory modernization, and better outcomes for patients.

If you are intellectually curious, energized by complex policy challenges, and passionate about advancing innovation in healthcare, we encourage you to apply.

Your Role

We are seeking a strategic, scientifically grounded, and highly collaborative Director, US Regulatory and Scientific Policy to help shape the regulatory environment supporting the development and delivery of innovative medical products. This role sits at the intersection of science, policy, and strategy, providing a unique opportunity to influence regulatory frameworks that impact patients, drug development, and healthcare innovation.

As a trusted advisor to Research & Development, Regulatory Affairs, and senior leadership, you will monitor emerging regulatory, legislative, and scientific policy trends; provide strategic insights to support development programs; and engage with regulators, industry associations, and other stakeholders to advance science-based regulatory frameworks. Candidates with experience in drug development, regulatory affairs, regulatory policy, and health authority engagement are encouraged to apply. Experience at FDA or another health authority is highly valued.

Key Responsibilities

• Monitor and assess evolving regulatory, legislative, scientific, and healthcare policy developments that may impact the company, its pipeline, and the broader drug development ecosystem.
• Provide strategic policy analysis and actionable recommendations to product teams, regulatory leaders, R&D stakeholders, and senior management.
• Advise development teams on regulatory opportunities, emerging pathways, policy risks, and innovative approaches that may accelerate development and patient access.
• Identify and help shape policy frameworks that support innovation in areas such as regulatory science, clinical development, digital health technologies, New Alternative Methods (NAMS), AI, rare diseases, and other emerging topics.
• Represent the company in interactions with trade associations, policy organizations, and other external stakeholders.
• Develop and advance company positions on key regulatory and legislative issues, including coordinating responses to guidance documents, requests for information, and other policy initiatives.
• Develop and support advocacy strategies that advance science-based, patient-focused regulatory policies.
• Develop briefing materials, policy analyses, presentations, executive communications, and training content for internal stakeholders.
• Serve as an internal subject matter expert in strategic policy areas and facilitate cross-functional collaboration across Regulatory Affairs, Clinical Development, Medical Affairs, CMC, Legal, Government Affairs, and other functions.
• Build strong internal and external relationships, lead through influence, and foster a culture of curiosity, innovation, continuous learning, and excellence.

Who You Are:

Minimum Qualifications:

• Bachelor's degree in biological sciences, healthcare, public health, policy, regulatory affairs, legal studies, or a related discipline with substantial relevant experience required; advanced degree strongly preferred (MS, PharmD, PhD, MD, MPH, JD, or equivalent),
• 5+ years of experience in pharmaceutical, biotechnology, regulatory, policy, government, consulting, or related fields.
• Strong knowledge of drug development and the regulatory environment governing pharmaceuticals and biologics.
• Understanding of FDA regulations, guidance development processes, and international regulatory frameworks, including ICH.

Preferred Qualifications:

• Experience at FDA, another health authority, or a policy-making organization.
• Experience developing regulatory policy positions and advancing regulatory reform initiatives.
• Excellent analytical, strategic thinking, communication, and problem-solving skills.
• Demonstrated ability to influence stakeholders and build consensus in a matrixed organization.
• Familiarity with legislative and healthcare policymaking processes.
• Experience working with trade associations, public-private partnerships, patient organizations, or multi-stakeholder collaborations.
• Demonstrated effectiveness engaging with senior executives, regulators, scientific experts, and industry leaders.
• Expertise in one or more emerging areas of regulatory science and innovation.

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!