Strategic Director, Global Regulatory & 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

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.