Director, Regulatory Affairs Jobs in Lexington, MA

Unlock the power of regulatory insights! Lead comprehensive monitoring and analysis of regulatory developments, providing actionable intelligence to guide business strategy and decision-making across...

Transform U.S. regulatory strategies in Obesity and Related Conditions, ensuring compliance and patient safety. Lead teams on global initiatives and manage key submissions for clinical trials and mark...

Shape the future of healthcare by leading strategic projects, managing teams, and delivering impactful solutions in market access and reimbursement. Collaborate closely with clients to drive innovatio...

Drive inspection readiness and compliance in a global role, leading initiatives and strategies to enhance GMP inspection management across internal and external operations, ensuring continuous improve...

Elevate your career by leading a high-impact CMC stability function, managing critical stability strategies across non-clinical, clinical, and commercial programs. Collaborate with diverse teams to en...

Join a team that's driving innovation in commercial growth, leading a dynamic group of sales specialists. You'll craft strategies that impact business revenue, foster talent, and enhance customer enga...

Join us to lead strategic and operational clinical development efforts, ensuring compliance and collaboration across multiple functions. Drive the execution of clinical trials and enhance organization...

Lead the charge in strategic clinical operations, overseeing development and execution of programs across multiple disciplines to align with corporate objectives and ensure operational excellence in a...

Transform quality management systems and GxP compliance by providing strategic, hands-on leadership to ensure robust, compliant systems. Collaborate across teams to enhance processes and maintain insp...

Reimagine clinical contract negotiations by joining a dynamic team committed to efficiency and compliance. Support various contract types and ensure streamlined processes while interfacing with stakeh...

Champion innovative access solutions by driving relationships with national payers and clients. Lead strategies that maximize patient access and profitability while collaborating with cross-functional...

Engage in managing quality assurance systems for clinical and medical affairs, ensuring compliance with global regulations. Collaborate cross-functionally to drive oversight and improve practices in p...

Engage with key stakeholders to develop and lead strategic policy initiatives that drive Travere Therapeutics' mission in rare disease advocacy and legislation. Collaborate cross-functionally to influ...

Join us in building a comprehensive compliance program that drives integrity and accountability as we transition into a commercial organization, ensuring adherence to regulatory standards and supporti...

Manage key regulatory functions, guiding compliance in PBM, pharmacy, and healthcare technology. Advise on state and federal obligations, and translate regulations into practical strategies for busine...

Engage with us to lead global CMC regulatory strategies for biologics, ensuring high-quality submissions and fostering collaborative interactions with Health Authorities while implementing AI-enhanced...

Unlock potential by leading trade strategy development and distribution optimization for a pioneering biopharmaceutical. Drive partnerships, manage logistics, and ensure compliance to enhance product...

Shape efficient product distribution strategies and manage key relationships with wholesalers and pharmacies. Monitor logistics, oversee contract negotiations and leverage market access expertise to d...

Unlock potential by leading regional regulatory strategies for innovative products. Collaborate effectively with global teams, ensuring compliance and fostering strong relationships with health author...

Empower quality assurance initiatives by overseeing GMP activities and collaborating with cross-functional teams to ensure compliance and quality in clinical and commercial products. Drive success in...

Shape the future of drug development by leading Drug Product activities, fostering collaboration across teams, and managing external partners to drive successful product advancement in alignment with...

Grow your expertise in GCP as you manage compliance for clinical studies, support regulatory inspections, and oversee quality assurance processes. Collaborate with cross-functional teams to enhance ef...

Lead the charge in advancing quality assurance for cutting-edge radiopharmaceuticals. Oversee development quality, regulatory compliance, and team leadership, ensuring alignment with GMP and enhancing...

Elevate analytics capabilities by leading data-driven strategies in market access and channel performance, supporting business needs with a mix of hands-on analysis and strategic insight...

Drive access to innovative therapies while collaborating with cross-functional teams to enhance patient support. This role focuses on navigating the reimbursement landscape and educating healthcare pr...