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...

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...

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...

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...

Champion safety excellence in explosives operations, enhance compliance through rigorous analyses, and ensure operational integrity in decontamination environments while fostering adherence to safety...

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...

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...

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...

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...

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...

Contribute to critical legislative efforts by analyzing congressional hearings, preparing documentation, and advising stakeholders. Collaborate with government officials to ensure timely responses and...

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...

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...

Transform global regulatory processes by leading approvals, strategizing submissions, and ensuring compliance for medical devices across diverse markets while collaborating with teams and serving as a...

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...

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...

Support quality assurance activities across the software development lifecycle. Collaborate with cross-functional teams to analyze, test, and ensure deliverables meet federal accessibility standards w...

Shape the future of military healthcare by providing expert regulatory guidance for acute care medical products, ensuring compliance with federal requirements, and supporting the development and submi...

Drive regulatory strategies and oversee compliance for investigational therapies. Work cross-functionally to ensure timely regulatory filings and maintain vendor relationships, contributing to clinica...

Shape the future of medical devices by leading regulatory strategies, ensuring compliance across global markets, and mentoring a dedicated team. Empower innovation through effective communication with...

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 the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...