Senior Regulatory Affairs Specialist Jobs in Rockville, 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...

Join a team that's advancing global health by supporting critical clinical trial submissions. In this role, you'll lead regulatory strategies, ensure compliance, and collaborate with diverse 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...

Champion regulatory strategies to accelerate product approvals and compliance. Lead a dynamic team in supporting innovative medical devices, ensuring alignment with global regulations while fostering...

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...

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...

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...

Drive global regulatory engagement and influence by creating evidence-based resources, collaborating across teams to enhance regulatory policies, and supporting public health standards worldwide. Impa...

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...

Transform regulatory strategies by providing CMC expertise to support product development and compliance in a dynamic pharmaceutical environment, ensuring quality and adherence to global standards thr...

Champion regulatory excellence by guiding product development teams, ensuring compliance with global standards, and fostering strong stakeholder relationships to drive business success...

Drive quality assurance initiatives by auditing computer system validations and documentation. Collaborate with cross-functional teams to ensure compliance with regulatory standards while managing con...

Innovate regulatory operations by managing submission preparation and execution, ensuring compliance with FDA and ICH standards. Collaborate cross-functionally to support complex filings and maintain...

Join a team that's committed to driving innovative regulatory projects, ensuring compliance, and collaborating with cross-functional teams to secure timely submissions and approvals for products in th...

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...

Shape the future of medical products by serving as a Senior Regulatory SME, guiding the development, submission, and compliance of military drugs, biologics, and medical devices. Collaborate cross-fun...

Champion global labeling strategy for innovative therapies, leading complex initiatives from development to post-approval. Collaborate with cross-functional teams to ensure compliance and high-quality...

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...

Lead the charge in regulatory operations for clinical trials, ensuring compliance and excellence from startup to closeout. Mentor a team of professionals while managing IRB submissions, documentation...

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...

Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...

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...

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...