Senior Regulatory Affairs Specialist Jobs in Gaithersburg, MD

Transform regulatory compliance by supporting submissions and documentation, ensuring adherence to standards, and collaborating with teams to navigate evolving regulations in a dynamic environment...

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

Elevate regulatory standards by serving as a senior SME for military-focused drugs and medical devices. Lead the development of submission strategies and mentor cross-functional teams in compliance pr...

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

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...

Collaborate with cross-functional teams to oversee regulatory activities for a portfolio of Pharmaceutical Diagnostics products, ensuring compliance and strategic alignment with global standards throu...

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...

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...

Advance regulatory strategy and submissions for CMC in pharmaceuticals, collaborating with cross-functional teams to ensure compliance with FDA, EMA, and ICH standards while overseeing product lifecyc...

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...

Lead the advancement of regulatory data strategy, governance, and digital ecosystems. Collaborate with cross-functional teams to enhance regulatory processes and data quality while executing innovativ...

Support quality assurance initiatives by ensuring compliance with FDA regulations, performing audits, managing deviations, and maintaining documentation for clinical trials to uphold the highest stand...

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

Champion CMC regulatory submissions by authoring high-quality dossiers for radiopharmaceuticals and biopharmaceuticals, ensuring compliance and collaboration across teams throughout the product lifecy...

Lead the charge in ensuring safety compliance and operational integrity for National Airspace System (NAS) operations through specialized analysis and collaboration with cross-functional teams...

Transform compliance through expertise in HR regulations, policy management, and training. Support a culture of accountability while navigating multi-state employment laws across diverse teams, ensuri...

Accelerate progress at the intersection of science and compliance, driving regulatory writing excellence for complex submissions while collaborating cross-functionally to ensure quality and timeliness...

Unlock potential by shaping global regulatory strategies that enable successful product launches. Collaborate across functions to ensure compliance and lead innovative submission processes throughout...

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...

Transform the regulatory landscape by leading labeling efforts for animal health products, ensuring compliance and excellence throughout the product lifecycle while collaborating with cross-functional...

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...

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...

Unlock potential by shaping global regulatory strategies and driving advocacy initiatives. Collaborate across teams to manage regulatory risks, assess opportunities, and provide strategic insights tha...

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...