Director, Regulatory Affairs Jobs

Empower innovation by leading strategic regulatory activities globally. Oversee INDs, CTAs, and Health Authority interactions while ensuring compliance and driving successful submissions in a fast-pac...

Contribute to regulatory excellence by leading teams to develop successful strategies for biotech and pharmaceutical projects, ensuring compliance with FDA and global agencies while enhancing innovati...

Accelerate progress at the forefront of pharmaceutical development by leading regulatory strategies. Collaborate cross-functionally to ensure timely submissions and compliance with FDA standards, driv...

Accelerate progress at the intersection of science and regulation by leading a global CMC team responsible for delivering high quality submissions for new biologics products while ensuring compliance...

Champion excellence in regulatory strategy for biologics while leading a dynamic CMC team. Drive global alignment, manage projects, foster cross-functional collaboration, and influence key stakeholder...

Innovate and execute regulatory CMC strategies for radiopharmaceutical products, ensuring compliance across global markets. Collaborate with cross-functional teams to support submissions and enhance p...

Champion regulatory excellence by leading a high-performing team in strategic submission oversight and compliance, ensuring timely approvals for a diverse product portfolio across US and Canadian mark...

Pioneer regulatory strategies for gene therapy products, overseeing submissions and collaborating across teams. Lead agency interactions, ensuring compliance and driving innovative drug development fo...

Join a dynamic team to lead global regulatory strategy for cutting-edge ophthalmology programs, ensuring alignment with development and commercialization goals while mentoring a high-performing regula...

Champion global regulatory strategies for ophthalmology programs, leading a team to navigate complex challenges in drug development while ensuring compliance and alignment with commercial objectives...

Unlock potential by driving global regulatory strategy and product safety. In this role, you will ensure compliance, guide teams, and foster innovative development while monitoring and mitigating regu...

Lead regulatory strategy for CAR-T and immunotherapy products, overseeing IND/IMPD and BLA submissions. Guide cross-functional teams, ensuring timely compliance and approvals while developing team mem...

Lead compliance for complex uranium remediation projects, ensuring adherence to regulatory standards, managing licensing, and collaborating with technical teams in a fast-paced environment. Drive safe...

Optimize regulatory CMC strategies for clinical and commercial products, leading cross-functional efforts to ensure compliance while monitoring global CMC trends and guiding teams through regulatory p...

Shape the future of regulatory compliance and product quality by leading global strategies, enhancing market entry processes, and integrating innovative systems to drive growth and operational excelle...

Empower global regulatory strategy for ophthalmology programs. Lead and develop a high-performing team to ensure alignment with drug development and commercialization goals, while representing the org...

Lead global regulatory strategy for ophthalmology programs, ensuring compliance and alignment with development goals. Supervise a high-performing team while engaging with health authorities to deliver...

Drive regulatory compliance and strategic rate development, collaborating with state and federal agencies. Lead proposals, testimony preparation, and direct communications with stakeholders to advocat...

Join a team that's shaping regulatory strategies in biopharmaceuticals. This role involves leading regulatory submissions and collaborating across project teams to ensure compliance while advancing co...

Champion the development of CMC regulatory submissions and strategies, ensuring compliance with global standards. Collaborate with cross-functional teams while maintaining accuracy in documentation to...

Lead the charge in managing CMC regulatory submissions and strategies, collaborating with cross-functional teams to ensure compliance and support the lifecycle of innovative therapies within a dynamic...

Empower your career by supporting critical CMC regulatory activities. Collaborate with cross-functional teams to ensure compliance and contribute to successful global submissions in an innovative biop...

Lead the charge in advancing global CMC regulatory strategies for gene therapy products. Oversee lifecycle management, change management, and compliance to ensure successful post-approval activities w...

Unlock your potential in a dynamic role overseeing regulatory affairs for drug development. Collaborate cross-functionally to shape regulatory strategies and ensure compliance with global guidelines w...

Empower our regulatory team by leading strategic labeling initiatives and ensuring compliance with FDA regulations for our product portfolio while collaborating cross-functionally to drive successful...