Regulatory Affairs Specialist Jobs in Frederick, MD

Shape the future of health technology by driving regulatory strategies for innovative lab testing, imaging, and AI products. Collaborate with cross-functional teams to ensure compliance and accelerate...

Take ownership of regulatory support for pharmaceutical programs, managing IND and NDA submissions, health authority interactions, and lifecycle maintenance. Collaborate with cross-functional teams to...

Drive regulatory intelligence initiatives to ensure compliance and support clinical research. Collaborate with experts to assess regulatory changes, track global guidelines, and enhance impact assessm...

Drive your career with a pivotal role in CMC regulatory affairs, ensuring compliance for biologics and small molecules. Collaborate across teams to prepare high-quality submissions and strategies, imp...

Join a team that shapes global regulatory strategy in a fast-paced environment. You will lead comprehensive regulatory plans, ensuring alignment and execution from development to post-marketing, impac...

Transform regulatory strategies for rare disease and cardio-pulmonary drug-device programs. Collaborate with cross-functional teams to ensure compliance and drive successful submissions globally, supp...

Elevate regulatory compliance by developing strategies for medical products, preparing submissions, and advising teams on risk management throughout the product lifecycle...

Optimize regulatory strategies by supporting advocacy efforts and analyzing payment policies. Collaborate with committees and healthcare organizations to influence key regulatory developments impactin...

Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...

Lead the charge in regulatory affairs by providing strategic guidance, ensuring compliance, and fostering collaboration across institutions. Drive initiatives from research to implementation while men...

Lead the charge in developing regulatory strategies for medical products, ensuring compliance with FDA standards. Collaborate with teams to navigate the product lifecycle and support submissions for d...

Lead the charge in developing regulatory strategies for medical products, ensuring compliance with FDA standards. Collaborate with teams to navigate the product lifecycle and support submissions for d...

Join a team that's shaping the future of medical products by developing regulatory strategies, preparing submissions, and advising on compliance throughout the product lifecycle. Collaborate with expe...

Engage with cross-functional teams to support regulatory pathways for innovative medical technologies, ensuring compliance and facilitating submissions for drugs, biologics, and medical devices in a d...

Help us advance public health by providing regulatory support and managing program records. Collaborate with stakeholders to ensure compliance and effective operations in a fast-paced, mission-driven...

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...

Elevate your career by serving as a senior regulatory SME for military-relevant drugs, biologics, and medical devices. Drive regulatory strategies, submissions, and agency interactions while mentoring...

Advance regulatory compliance by preparing and submitting IND/IDE applications, ensuring adherence to FDA standards while collaborating with clinical teams to support groundbreaking genomics research...

Elevate compliance standards by providing expert guidance on FDA CGMP regulations, advising clients on inspection readiness, and collaborating with cross-functional teams to ensure adherence to qualit...

Support compliance in Quality Control by managing investigations and quality records. Collaborate on metrics reporting and ensure adherence to regulatory standards for GMP manufacturing of biological...

Optimize the promotional review process by coordinating cross-functional workflows, ensuring compliance, and facilitating timely approvals of marketing materials. Collaborate with internal and externa...

Champion regulatory excellence by leading U.S. FDA engagement and strategy for product development, ensuring timely approvals and compliance while driving cross-functional collaboration and organizati...

Drive compliance excellence by managing change control, CAPA, and risk assessments. Collaborate with teams to ensure regulatory adherence and support continuous improvement initiatives across engineer...

Empower regulatory excellence by guiding cross-functional teams in compliance and strategy. Leverage deep FDA knowledge to influence promotional materials and ensure adherence to evolving regulations...

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...