Senior Regulatory Affairs Specialist Jobs in Rockville, MD

Optimize product labeling and artwork compliance by collaborating with cross-functional teams to ensure accuracy and adherence to FDA regulations, while mentoring junior staff and driving strategic in...

Champion regulatory excellence by leading CMC strategies for small molecule programs, ensuring compliance and driving successful submissions from early development through commercialization in a dynam...

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...

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Lead compliance excellence by conducting quality reviews, enhancing processes, and providing expert guidance to ensure timely, accurate client service and adherence to regulatory standards in a dynami...

Drive enterprise Quality and Regulatory governance for U.S. operations, ensuring compliance with FDA regulations and overseeing manufacturing quality in the therapeutic radiopharmaceutical sector whil...

Champion the U.S. Biologics Regulatory CMC team by providing strategic leadership, ensuring timely regulatory submissions, and fostering collaboration among global stakeholders to drive innovative bio...

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

Elevate your career by leading global CMC regulatory strategies for biologics. Collaborate with cross-functional teams, ensure compliance, and drive successful product development while mentoring a hi...

Champion quality systems and compliance in a global organization, ensuring regulatory readiness and customer support. Collaborate with stakeholders to maintain documentation and resolve complex qualit...

Engineer high-quality analytical solutions in a dynamic QC environment. Leverage your expertise in molecular biology and protein chemistry to support GMP manufacturing and mentor laboratory staff whil...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Lead engineering initiatives to enhance equipment reliability and efficiency in biopharma manufacturing. Collaborate cross-functionally to optimize processes and ensure compliance while mentoring team...

Engage with government and regulatory bodies to shape automotive safety and technology policies. Lead communications, manage submissions, and foster collaboration across teams to ensure compliance and...

Join us to lead enterprise-level proposal operations, overseeing complex, multi-volume proposals for large-scale acquisitions. Collaborate with cross-functional teams to ensure compliant, competitive...

Elevate your career by leading CMC Regulatory strategy and execution. Drive submissions, build a high-performing team, and engage with global health authorities to ensure compliance and success in dru...

Partner with us to innovate and transform Quality & Regulatory operations through technology and data analytics. Drive automation, improve efficiency, and foster effective digital solutions that enhan...

Unlock potential by leading regulatory strategies for innovative medical devices. Collaborate with teams to ensure compliance, execute FDA submissions, manage project timelines, and establish processe...

Join us to lead utility rebate and incentive efforts for geothermal heating. Collaborate with our Policy team to shape regulatory strategies and build relationships with key stakeholders across multip...

Elevate quality and compliance as you lead validation strategies across cross-functional teams, ensuring robust testing and regulatory adherence in a dynamic GMP environment. Drive innovation and oper...

Elevate quality assurance by managing protein-based immunoassays, troubleshooting failures, and leading cross-functional teams to ensure compliance and enhance product performance in a dynamic lab env...

Transform healthcare engagement by building relationships with HCPs through digital interactions and telephone conversations, promoting products, and achieving sales goals while ensuring compliance wi...

Shape the future of pharmaceutical validation by leading technical work streams, mentoring junior staff, and ensuring compliance with cGMP standards. Drive project success through expert problem-solvi...

Join a team that's shaping regulatory strategies for advertising and promotion. Leverage your expertise to ensure compliance while collaborating with cross-functional teams to drive impactful product...

Contribute to innovative cell therapy product characterization by leading method development, analyzing complex datasets, and collaborating across teams to ensure quality and efficacy from preclinical...