Director, Regulatory Affairs Jobs in Gaithersburg, MD

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...

Shape global CMC regulatory strategies for innovative cell and gene therapies, driving successful approvals through robust submissions, stakeholder collaboration, and effective risk management to enha...

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 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...

Transform manufacturing operations by leading key growth projects in bioconjugate drug substance production. Ensure GMP compliance and operational readiness through strategic process management and cr...

Unlock compliance excellence by leading regulatory initiatives and ensuring adherence to quality standards in aseptic manufacturing and sterile operations. Drive continuous improvement and foster a cu...

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...

Shape a global go-to-market strategy to enhance commercial operations and drive market share growth. Leverage strategic thinking and execution skills while collaborating with diverse teams to streamli...

Empower operational excellence in bioconjugate manufacturing projects. Drive readiness strategies from design through start-up, ensuring GMP compliance and organizational success while collaborating w...

Champion operational readiness for U.S. growth projects in bioconjugate manufacturing, driving facility design and ensuring GMP compliance from start-up to routine operations while building a high-per...

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

Transform chronic weight management strategies on a global scale, driving evidence generation and medical communication while leading cross-functional collaboration to deliver impactful healthcare sol...

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...

Join a dynamic team to lead clinical studies, ensuring strategic execution and oversight in neuropsychiatric drug development. Drive collaboration across departments and contribute to regulatory frame...

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...

Join a team that's dedicated to advancing regulatory strategies for innovative SaMD products. Collaborate cross-functionally to drive compliance, manage documentation, and ensure readiness for audits...

Take ownership of enterprise Quality Data Analytics initiatives, driving program execution and data-driven transformations. Lead cross-functional teams to enhance compliance, risk management, and deci...

Lead and drive strategic initiatives as Director of Process & Analytical Development, ensuring operational excellence and compliance in a rapidly evolving environment. Focus on team development, colla...

Elevate operational excellence by leading analytical and process development initiatives. Drive strategic direction, enhance capabilities, and foster innovation while ensuring compliance and efficienc...

Champion scientific integrity by driving study design and reporting results. Oversee the entire nonclinical study lifecycle, ensuring compliance and effective communication with all stakeholders while...

Drive regulatory strategy by collaborating cross-functionally to influence promotional activities, ensuring compliance while optimizing risk management for impactful business decisions across a dedica...

Optimize quality management systems to enhance compliance and operational efficiency. Collaborate across departments to ensure best practices in GxP regulations, driving continuous process improvement...

Lead the charge in GMP API Quality Assurance, overseeing compliance and performance management with external manufacturers. Collaborate cross-functionally to ensure inspection readiness and support a...

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...