Director, Regulatory Affairs Jobs in Gaithersburg, MD

Lead strategic project management for global commercialization initiatives within one of the key Disease Areas. Drive execution, foster alignment across teams, and support launch readiness in a growin...

Empower innovation at the intersection of technology and law. Guide product, engineering, and compliance teams in navigating regulatory landscapes and mitigating risks related to AI and machine learni...

Drive the strategic vision for integrations, championing growth through partnerships and innovative solutions. Lead product delivery and partner success, ensuring alignment across enterprise ecosystem...

Unlock potential by developing impactful policy content that shapes public health initiatives and drives scientific rigor. Collaborate across diverse teams to enhance access to quality medicines while...

Join a forward-thinking team as you shape the future of digital health policy, driving advocacy and collaboration with regulatory authorities while navigating complex medical device standards and AI f...

Tackle clinical regulatory writing by leading teams, authoring documents, and driving strategy for submissions to ensure high standards and timely delivery across a diverse portfolio in a collaborativ...

Join us to drive early clinical development initiatives and enhance our robust pipeline. Lead trials from strategy to execution, ensuring compliance and collaboration across teams to advance innovativ...

Unlock potential by shaping scientific validation and regulatory engagement in Advanced Cell Models, leading a team to foster innovation and sustainable growth within the pharmaceutical sector. Drive...

Champion strategic growth by leading the charge to secure complex health system accounts. Drive transformative deals with hands-on coaching, leveraging deep relationships and expertise to elevate team...

Optimize safety evaluations within our Drug Safety team to drive innovative strategies for monitoring and managing clinical risks, ensuring compliance and maintaining high-quality standards in pharmac...

Lead the development and execution of global medical affairs strategies, focusing on oncology assets. Collaborate cross-functionally to optimize asset utilization and drive impactful medical communica...

Lead the charge in clinical pharmacology strategies for rare disease and oncology programs, driving innovative solutions, study designs, and regulatory interactions to expedite drug development and im...

Empower your career by leading our Quality Management System and cultivating a quality-centric culture. Collaborate across teams to define standards, manage audits, and support regulatory compliance a...

Lead the charge in early clinical development for innovative drug therapies. Collaborate with multidisciplinary teams to advance clinical trials and ensure compliance with industry regulations while d...

Elevate global commercialization strategies for Companion Diagnostic products. Collaborate with cross-functional teams to ensure successful CDx launches while maximizing partner value and driving sust...

Join a team that's building a global compliance function from the ground up. Lead strategy, governance, and operational excellence while partnering with business leaders to drive compliance as a key e...

Support Congressional and interagency relations while providing expert guidance on national security reporting, legislative matters, and executive communications to enhance organizational engagement a...

Champion impactful litigation and policy strategies to drive innovation and access to medicines. Collaborate with legal and business leaders to navigate the regulatory landscape while managing complex...

Elevate regulatory standards by serving as a senior SME for military-focused drugs and medical devices. Lead the development of submission strategies and mentor cross-functional teams in compliance pr...

Champion effective tax strategies by overseeing compliance and reporting. Leverage expertise to manage the tax provision process, ensuring timely completion of returns and supporting strategic plannin...

Join a dynamic team to lead global marketing initiatives in healthcare, focusing on strategic brand launch, promotional campaigns, and cross-functional collaboration for a first-in-class product, driv...

Lead the charge in global clinical data management strategy and oversight. Drive data integrity, standardize processes, and ensure compliance across all phases of clinical trials, while building a hig...

Transform how leaders access and understand information by leading the technical vision for BI reporting and analytics. Drive innovation with emerging capabilities like AI, translating business strate...

Drive product excellence by owning the lifecycle and security of high-performance client SaaS platforms hosted on AWS. Lead a dedicated team to optimize operations, ensure compliance, and deliver seam...

Pioneer early-phase clinical trials by managing cross-functional teams, ensuring compliance, and maintaining budgets. Drive proactive issue resolution and enhance sponsor relationships while deliverin...