Director, Global Regulatory and Scientific Policy

The businesses of Merck KGaA, Darmstadt, Germany • Washington, DC

10h

About The Position

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. 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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Access and opportunities for all to develop and grow at your own pace.
• Inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

What This Job Offers

• Job Type: Full-time
• Career Level: Director