Director, Regulatory Affairs Jobs in Gaithersburg, MD

Champion operational excellence and strategic partnerships in the clinical research space. Drive financial performance and enhance client satisfaction while leading high-performing teams to achieve su...

Drive impactful regulatory projects by leading teams and advising federal clients in environmental policy. Utilize your extensive experience to manage complex challenges with a focus on collaboration...

Develop and communicate strategic regulatory directions while overseeing multiple CMC projects. Lead cross-functional teams and ensure compliance. Build relationships with stakeholders and Health Auth...

Transform regulatory writing by leading complex submissions, mentoring teams, and ensuring compliance. Drive innovation and improve processes while collaborating across teams to enhance product succes...

Shape your impact by leading government affairs initiatives, fostering relationships with policymakers, and advocating retail priorities in a dynamic environment. Collaborate with senior leaders to na...

Elevate your career by leading MSAT initiatives driving small molecule drug manufacturing. Oversee the entire facility lifecycle ensuring robust processes, compliance, and operational readiness in col...

Drive process readiness and compliance for small molecule manufacturing operations. Lead cross-functional teams in facility design, qualification, and handover, ensuring robust processes and regulator...

Elevate our global labeling strategy by leading end-to-end processes, driving compliance, and optimizing product positioning through precise, defensible labeling language while collaborating across te...

Elevate your career by leading the strategy for science and FDA policy initiatives. Collaborate with experts to enhance biopharmaceutical research and influence critical regulatory frameworks, ensurin...

Bring your expertise to a dynamic team as you lead high-impact medical content development. Collaborate cross-functionally, mentor talent, and strategize with clients to enhance medical education and...

Champion global access programs for innovative cancer therapies, ensuring alignment with clinical, regulatory, and patient needs. Lead cross-functional teams to enhance early access strategy and opera...

Shape the future of compliance by leading global regulatory strategies. Drive initiatives in Trade Compliance, Anti-Bribery, and more, influencing business growth and advocating for best practices acr...

Lead the charge in ensuring quality compliance by conducting thorough GMP and GDP audits across Gilead’s global manufacturing and supply network, enhancing internal policies and external partnerships...

Drive global CMC regulatory strategies and submissions for clinical and commercial products. Collaborate cross-functionally to ensure compliance, lifecycle management, and timely delivery of high-qual...

Accelerate progress at a cutting-edge pharmaceutical project, leading operational readiness and ensuring compliance from design to start-up. Collaborate cross-functionally to build a high-performing o...

Drive regulatory excellence by leading high-priority document authoring and ensuring compliance for U.S. tobacco product submissions. Collaborate cross-functionally to enhance regulatory strategies an...

Advance your career by leading operational readiness for a growth project in small molecule drug substance manufacturing. This role requires strategic oversight of facility design through to operation...

Drive compliance and legal support for regulatory affairs, guiding teams through complex healthcare laws while leading a high-performing legal group to enhance operational efficiency and navigate legi...

Lead the charge in Medical Affairs, driving strategy, team development, and external engagements. Oversee compliance and scientific rigor while fostering partnerships with KOLs and managing budget and...

Empower industry insights by analyzing and articulating the impact of regulatory changes in European life sciences, delivering high-quality content, and engaging with stakeholders to inform regulatory...

Lead the charge in shaping legislative strategies for life sciences, guiding advocacy efforts and providing executive counsel while fostering strategic partnerships at federal and state levels to infl...

Innovate robust global regulatory frameworks to enhance compliance, drive quality initiatives, and support strategic goals across diverse teams while ensuring adherence to international standards and...

Unlock the power of regulatory insights! Lead comprehensive monitoring and analysis of regulatory developments, providing actionable intelligence to guide business strategy and decision-making across...

Lead the charge in global regulatory strategies for innovative medical devices, driving project success from registration to compliance. Collaborate across teams to enhance healthcare technologies and...

Reimagine clinical contract negotiations by joining a dynamic team committed to efficiency and compliance. Support various contract types and ensure streamlined processes while interfacing with stakeh...