Director, Regulatory Affairs Jobs

Join a team that's dedicated to ensuring quality compliance in clinical and manufacturing programs. You'll oversee GMP processes, guide teams through regulations, and foster a culture of continuous im...

Deliver expert toxicology insights to enhance safety assessments, guide study designs, and ensure timely evaluations of drug candidates, while effectively collaborating with drug discovery teams and r...

Drive US regulatory strategies for impactful product development. Collaborate with global teams, lead FDA interactions, and ensure timely submissions, enhancing patient access through expedited pathwa...

Help us drive US regulatory strategies for critical therapeutic products. Collaborate with global teams and interact directly with FDA to expedite patient access while ensuring compliance with evolvin...

Elevate regulatory compliance by analyzing drug quality databases, ensuring data integrity and FDA adherence. Collaborate with stakeholders to deliver actionable insights that enhance decision-making...

Launch your career by supporting regulatory submissions and compliance activities, coordinating documentation, and engaging in team collaborations to drive successful outcomes in drug development and...

Engage in strategic leadership for non-sterile manufacturing operations, ensuring compliance and efficiency in packaging and assembly. Drive continuous improvement and operational excellence in alignm...

Lead the charge in strategic oversight of regulatory advertising and promotion initiatives, driving cross-functional collaboration and innovation while managing departmental operations and budgetary n...

Take ownership of the quality and regulatory systems to ensure product excellence and compliance. Lead global strategies, audits, and continuous improvement initiatives while collaborating with cross...

Oversee the development and execution of global regulatory strategies, ensuring high-quality submissions and compliance with health authority standards while collaborating with internal teams and exte...

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...

Shape global Quality & Regulatory strategy for Biomedical, driving compliance, continuous improvement, and operational excellence across all functions while leading a high-performing team in a highly...

Join a team that's shaping global regulatory strategies to ensure compliance and drive product success. Lead the regulatory efforts for innovative therapies while collaborating with stakeholders to mi...

Unlock regulatory success by leading the US strategy for groundbreaking gene therapy initiatives. Collaborate with global teams, manage submissions, and mitigate risks while navigating the dynamic lan...

Lead the charge in regulatory strategy, overseeing milestone execution from IND to post-marketing. Collaborate with senior management to guide program teams and ensure excellence in project management...

Join a team that's committed to driving regulatory excellence and strategic leadership in managing critical milestones across therapeutic areas from IND approval to post-marketing. Enhance your impact...

Innovate clinical research by leading study activities, collaborating cross-functionally, and generating crucial evidence to drive product development and growth. Elevate your leadership skills while...

Unlock potential by driving product innovations and compliance strategies in collaboration with cross-functional teams, ensuring regulatory adherence while enabling market success and protecting opera...

Optimize quality operations in cGMP manufacturing for cell therapy, ensuring compliance while driving continuous improvement and fostering a culture of quality through collaboration with cross-functio...

Join us to oversee complex CMC regulatory projects and lead cross-functional teams. Develop strategic direction from global guidelines while ensuring compliance. Represent at key health authority meet...

Tackle the global expansion of Compliance and Legal Services by building a cohesive service portfolio. Lead strategic initiatives, digital transformations, and ensure service excellence through govern...

Join a team that's shaping the future of biopharmaceuticals by developing CMC regulatory strategies. Collaborate with internal and external partners, ensuring first-pass approvals and driving project...

Innovate processes by leading technical studies, ensuring compliance, and driving accurate reporting while coordinating with clients and teams to exceed expectations and maintain quality standards for...

Shape the future of compliance by overseeing quality assurance for regulatory submissions and lifecycle management of innovative biotherapeutics, ensuring adherence to US and EU GMP requirements while...