Senior Regulatory Affairs Specialist Jobs in Rockville, MD

Lead the development and execution of global CMC regulatory strategies to support clinical trials and market applications, ensuring compliance with regulatory requirements throughout the product lifec...

Empower your career by leading global regulatory strategies for medical devices and diagnostics. Collaborate with cross-functional teams to ensure compliance and drive market access while mentoring ot...

Join a team that's shaping the future of military healthcare by providing expert regulatory guidance on drugs, biologics, and medical devices. Collaborate with cross-functional teams to develop strate...

Contribute to regulatory strategies for military-relevant drugs, biologics, and medical devices. Mentor teams, prepare submissions, and engage with FDA and other agencies to ensure compliance and opti...

Optimize operations by leading continuous improvement initiatives across North America. Collaborate with teams to implement lean management systems, enhance efficiency, and drive productivity while fo...

Champion regulatory excellence by leading cross-functional teams, ensuring compliance, and driving successful oncology drug development through strategic planning and expert guidance...

Manage regulatory activities for advertising and promotion, ensuring compliance while collaborating with cross-functional teams to develop impactful product messaging and materials that align with com...

Unlock your potential as a Global Regulatory Leader, driving regulatory strategy and submissions for CNS projects. Collaborate with cross-functional teams, mentor junior staff, and ensure compliance w...

Lead regulatory compliance programs ensuring inspection readiness and proactive risk management across cross-functional teams. Monitor compliance health, manage data quality, and drive improvements al...

Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...

Join a team that's advancing regulatory strategies for drug substance manufacturing. Lead the charge in selecting and justifying Regulatory Starting Materials, ensuring compliance with global guidelin...

Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...

Empower your career by leading regulatory advertising initiatives, ensuring compliance while collaborating with cross-functional teams to develop impactful product messaging for marketed and pipeline...

Drive regulatory strategy across major programs, leading high-impact submissions and authority engagement. Collaborate with cross-functional teams to optimize clinical development and ensure complianc...

Unlock potential by leading regulatory compliance for IVD products, ensuring adherence to global standards. Collaborate with cross-functional teams to assess risks, manage adverse events, and drive co...

Join a global team to shape regulatory strategies in biotechnology, supporting product development and lifecycle management in Inflammation and Rare Diseases. Lead regulatory efforts, ensure complianc...

Unlock potential by leading regulatory writing for complex submissions, mentoring junior writers, and driving departmental initiatives. Collaborate with cross-functional teams to ensure compliance and...

Lead the charge in quality assurance by managing complex projects, mentoring team members, and driving improvements in product performance. Utilize your expertise in protein-based immunoassays to ensu...

Optimize regulatory processes by ensuring compliance with FDA submissions and guidelines. Collaborate cross-functionally to review and approve applications, enhancing the quality and accuracy of submi...

Join a dynamic team as a Senior ISO 9001 Quality Management Specialist, providing expertise in quality management systems and continuous improvement for federal programs. Drive operational excellence...

Join a team that's driving innovation in R&D and Regulatory processes. Leverage your Veeva RIM expertise, manage global compliance systems, and implement solutions that meet dynamic business needs whi...

Elevate quality assurance standards by leading a skilled team to develop, implement, and maintain robust quality management systems for critical IT solutions, ensuring compliance and operational excel...

Advance your career by leading clinical research projects and ensuring compliance with timelines and standards. Collaborate with stakeholders and clinical sites to safeguard subjects' rights and data...

Champion the regulatory strategy for starting materials in drug manufacturing, ensuring compliance with ICH Q11 and regional guidelines. Collaborate cross-functionally to support late-stage clinical a...

Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...