Director, Regulatory Affairs Jobs in Waltham, MA

Join a dedicated team driving global regulatory strategy for early-stage oncology products. You'll execute and manage high-quality submissions and collaborate across functions to ensure compliance and...

Optimize global regulatory strategy for cutting-edge cell therapies, leading high-impact programs from development through licensure. Collaborate with teams, ensure competitive pathways, and drive pat...

Shape compliance strategies across hardware and biotech sectors, ensuring products meet global regulatory standards and collaborating with cross-functional teams to drive innovative solutions and main...

Collaborate with cross-functional teams to lead regulatory writing efforts, ensuring high-quality documentation throughout the drug development lifecycle, from preclinical to registration stages, to s...

Transform global GxP compliance by leading a high-performing Quality team, overseeing audits, inspection readiness, and strategic initiatives to ensure effective governance across the organization's Q...

Support scientific operations across research programs, managing data rooms and IP workflows. Collaborate with leaders to ensure program accuracy and readiness, driving process improvements in a fast...

Lead the charge in analytical development for radiopharmaceuticals, providing strategic oversight and collaborative support to ensure compliance with GMP and regulatory standards throughout product de...

Contribute to innovative global regulatory strategies ensuring product compliance for the pharmaceutical portfolio. Drive regulatory leadership, manage agency interactions, and enhance internal proces...

Lead compliance and regulatory activities for medical devices, ensuring adherence to FDA and international standards while managing risk assessments and product recalls. Collaborate cross-functionally...

Drive compliance and regulatory strategy by evaluating product changes, managing post-market activities, and coordinating across departments to ensure adherence to global regulations, supporting safet...

Elevate the quality management systems by overseeing compliance, driving continuous improvement, and leading cross-functional efforts to harmonize processes in a regulated environment, ensuring effect...

Shape the future of Quality Management by leading ISO 9001 compliance efforts and fostering a culture of continuous improvement while developing a high-performing team to ensure operational excellence...

Elevate the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...

Shape the future of drug substance development by leading regulatory strategies for starting materials. Collaborate cross-functionally and ensure compliance with global regulations to support late-sta...

Shape global regulatory strategies by providing leadership and expertise in drug development. Collaborate with teams to ensure compliance and influence regulatory authorities for better outcomes...

Champion the future of Regulatory Strategy for groundbreaking mRNA vaccine programs. Lead strategic direction and ensure compliance with global health agencies, while driving innovative regulatory ini...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Join a dynamic team to lead regulatory project management, ensuring timely and compliant submissions to health authorities. Collaborate cross-functionally to align project goals, manage risks, and dri...

Transform aseptic quality assurance by leading a high-performing team, driving compliance through effective monitoring and training, and ensuring best practices in contamination control to deliver top...

Join a team that's redefining operational excellence by leading quality assurance, compliance, and governance initiatives across segments, ensuring standards are met while fostering collaboration and...

Lead and optimize the compliance function with a strategic focus on regulatory readiness, risk management, and team development. Collaborate cross-functionally to ensure practical compliance embedded...

Shape global trade strategies while ensuring compliance and operational excellence. Drive transformation and influence executive leadership to support innovation-driven growth across life sciences. Le...

Lead the charge in quality operations, overseeing compliance and governance for external manufacturing partners, and ensure timely quality decisions for clinical and commercial products in a dynamic...

Drive innovation in precursor development, optimizing manufacturing processes while ensuring compliance with regulatory standards to deliver high-quality radiopharmaceutical products for clinical and...

Drive global regulatory strategy for marketed products, ensuring compliance with local regulations. Collaborate across functions to support submissions and maintain market access, while guiding teams...