Director, Regulatory Affairs Jobs in Gaithersburg, MD

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Shape regulatory strategies for CMC in cell therapy programs and collaborate across teams to ensure compliance with health authority requirements, supporting trials and product approvals throughout th...

Unlock potential by leading CMC regulatory strategies for cell therapies. Collaborate across teams to ensure compliance, prepare submissions, and drive product lifecycle success, while engaging with g...

Empower progress at the intersection of regulatory compliance and cell therapy. Lead CMC strategies for global submission readiness, partnering with cross-functional teams to navigate approvals, and e...

Join a team that's shaping the future of global regulatory affairs. You will lead compliance strategies for investigational products and marketing applications through effective submissions and collab...

Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...

Join a team that's dedicated to ensuring compliance in promotional activities for CNS treatments while navigating regulatory pathways in a fast-paced environment. Help shape communications, drive stra...

Empower regulatory excellence by supporting compliance activities, SOP maintenance, and cross-functional collaboration. Drive inspection readiness and enhance operational efficiency in a fast-paced, g...

Optimize regulatory processes by ensuring compliance with FDA submissions and guidelines. Collaborate cross-functionally to review and approve applications, enhancing the quality and accuracy of submi...

Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

Champion CMC regulatory submissions by authoring high-quality dossiers for radiopharmaceuticals and biopharmaceuticals, ensuring compliance and collaboration across teams throughout the product lifecy...

Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...

Transform global regulatory strategies for CMC in Cell & Gene Therapy. Lead a team of experts, ensuring compliance with international regulations. Collaborate cross-functionally and drive successful p...

Explore an impactful leadership role managing global CMC RA teams, ensuring compliance and strategic direction for Cell & Gene Therapy products throughout their lifecycle, while fostering collaboratio...

Lead the charge in global CMC regulatory strategy for Cell & Gene Therapy, ensuring compliance across development, registration, and lifecycle management. Oversee regulatory submissions and provide st...

Lead the charge in regulatory compliance for promotional and labeling strategies, ensuring alignment with FDA regulations while collaborating with cross-functional teams to achieve business objectives...

Champion regulatory excellence by leading U.S. FDA engagement and strategy for product development, ensuring timely approvals and compliance while driving cross-functional collaboration and organizati...

Lead the charge in regulatory operations for clinical trials, ensuring compliance and excellence from startup to closeout. Mentor a team of professionals while managing IRB submissions, documentation...

Engage in dynamic regulatory project management, driving success for biotech clients. Oversee diverse projects, ensure timely submissions, and foster client relationships while contributing to strateg...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Drive global regulatory engagement and influence by creating evidence-based resources, collaborating across teams to enhance regulatory policies, and supporting public health standards worldwide. Impa...

Lead the development of global regulatory strategies and ensure compliance throughout the product lifecycle, from pre-approval to post-approval, as a strategic partner and advisor to cross-functional...

Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...