Director, Regulatory Affairs Jobs in Gaithersburg, MD

Lead the charge in developing global regulatory strategies for clinical programs. Manage regulatory operations for product lifecycle while collaborating with cross-functional teams to ensure successfu...

Empower global product strategy in Regulatory Affairs, leading teams to navigate complex regulations for therapeutic developments in inflammation and rare diseases. Drive global registration and lifec...

Lead the charge in global regulatory strategy for vaccine and infectious disease projects, ensuring effective oversight, collaboration with cross-functional teams, and engagement with regulatory agenc...

Elevate quality compliance across global operations by leading audit teams, ensuring adherence to regulations, and fostering a culture of continuous improvement to enhance manufacturing processes and...

Shape the future of energy regulation by analyzing market rules, developing strategies, and fostering alliances. Engage with stakeholders and drive policy efforts to advance regulatory interests in th...

Drive global regulatory labeling initiatives, ensuring compliance and quality of documentation across diverse markets. Lead strategic governance, influence policies, and collaborate cross-functionally...

Champion global regulatory strategy for innovative cell therapies, guiding pivotal programs from development through approval, while ensuring alignment with market and patient needs in a high-impact...

Lead the development of innovative promotional regulatory strategies that ensure compliance and empower teams in the pharmaceutical sector to effectively communicate with healthcare professionals and...

Take ownership of a comprehensive compliance program, ensuring regulatory readiness and effective oversight across multiple states in telehealth. Lead a team dedicated to establishing policies and fos...

Accelerate the global regulatory strategy for innovative cell and gene therapies, guiding programs through complex pathways to approval while ensuring alignment with product goals and patient needs fo...

Elevate your career in government affairs by driving advocacy efforts and strategic relationships that improve patient access and influence federal policy decisions in the pharmaceutical industry. Col...

Collaborate with stakeholders to shape impactful cancer research policies and regulatory strategies. Drive initiatives that enhance dialogue between researchers and policymakers, fostering innovation...

Engage with cross-functional teams to ensure regulatory compliance for Expanded Access Programs. Drive essential strategies and submissions while staying aligned with global legislation, impacting pat...

Transform the biopharmaceutical landscape by advising clients on regulatory compliance and clinical pharmacology strategies, leveraging your expertise to impact innovative drug development across dive...

Champion the advancement of biopharmaceuticals by leading US regulatory policy efforts, developing strategies, engaging with stakeholders, and influencing key decisions to support GSK’s portfolio and...

Lead US regulatory policy and advocacy efforts, shaping biopharmaceutical strategies to navigate a dynamic regulatory landscape and enhance GSK's portfolio with impactful outcomes for patients...

Lead the charge in developing and implementing regulatory strategies for oncology products. Oversee complex submissions, agency interactions, and drive cross-functional alignment to ensure rapid appro...

Lead the charge in advancing policy development through rigorous research and analysis of pharmaceutical pricing and market access issues, enhancing advocacy strategies, and collaborating across teams...

Join a team that provides regulatory legal guidance across various industries, ensuring compliance and supporting business operations. Leverage your expertise in federal and state regulations to manag...

Lead the charge in managing a bioanalytical laboratory, ensuring compliance, quality, and strategic direction while fostering a team environment and implementing continuous quality improvements to enh...

Empower quality excellence as a key leader in biologics, driving compliance, performance, and a culture of innovation while overseeing a robust quality unit and fostering cross-functional partnerships...

Lead the charge in advancing corporate advocacy strategies across global, federal, and state governments. Collaborate with internal teams and external stakeholders to influence policy outcomes and sup...

Lead and manage a global Pharmacovigilance audit program, ensuring compliance with regulations and industry best practices. Collaborate with cross-functional teams to enhance processes and drive conti...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

Join our team to lead regulatory strategies across major programs, driving impactful submissions and fostering collaboration within a challenging and dynamic environment. Embrace the opportunity to in...