Senior Regulatory Affairs Specialist Jobs in Gaithersburg, MD

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Empower effective regulatory strategy development for HCT/P and combination products. Lead submissions and audits while ensuring compliance with FDA standards. Collaborate with teams to foster excelle...

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...

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...

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 regulatory compliance for promotional and labeling strategies, ensuring alignment with FDA regulations while collaborating with cross-functional teams to achieve business objectives...

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...

Drive regulatory compliance by developing strategies for medical products. Collaborate with teams, support submissions, and conduct analyses to mitigate risks throughout product lifecycles in a fast-p...

Unlock potential by leading regulatory strategies for medical products, ensuring compliance and guiding projects from inception to market. Collaborate with teams to navigate FDA interactions and suppo...

Join a team that's shaping the future of global regulatory affairs. You will lead compliance strategies for investigational products and marketing applications through effective submissions and collab...

Join a dynamic team as you drive regulatory strategies and ensure compliance in post-approval activities for CMC processes. Collaborate cross-functionally, influencing clinical outcomes and advancing...

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...

Champion global regulatory strategies by leading diverse teams in navigating complex approval processes for medical devices. Drive compliance and ensure optimal product launch pathways while addressin...

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

Join a team that's dedicated to ensuring compliance in promotional activities for CNS treatments while navigating regulatory pathways in a fast-paced environment. Help shape communications, drive stra...

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...

Transform global regulatory strategies for CMC in Cell & Gene Therapy. Lead a team of experts, ensuring compliance with international regulations. Collaborate cross-functionally and drive successful p...

Explore an impactful leadership role managing global CMC RA teams, ensuring compliance and strategic direction for Cell & Gene Therapy products throughout their lifecycle, while fostering collaboratio...

Lead the charge in global CMC regulatory strategy for Cell & Gene Therapy, ensuring compliance across development, registration, and lifecycle management. Oversee regulatory submissions and provide st...

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...

Shape regulatory strategies for CMC in cell therapy programs and collaborate across teams to ensure compliance with health authority requirements, supporting trials and product approvals throughout th...

Unlock potential by leading CMC regulatory strategies for cell therapies. Collaborate across teams to ensure compliance, prepare submissions, and drive product lifecycle success, while engaging with g...

Empower progress at the intersection of regulatory compliance and cell therapy. Lead CMC strategies for global submission readiness, partnering with cross-functional teams to navigate approvals, and e...

Join a team that's shaping the future of aviation by providing strategic legal counsel on regulatory matters. You'll engage with federal agencies, develop advocacy strategies, and translate complex is...