Regulatory Affairs Specialist Jobs in Gaithersburg, MD

Champion regulatory policy initiatives by analyzing FDA guidances and research, conducting landscape analysis, and advocating for strategic alignment across functions to enhance patient access and opt...

Advance regulatory compliance by managing global submissions and technical documentation for medical devices, supporting product lifecycle management and market expansion to ensure adherence to EU MDR...

Join a team that shapes global regulatory strategy in a fast-paced environment. You will lead comprehensive regulatory plans, ensuring alignment and execution from development to post-marketing, impac...

Drive impactful regulatory projects by leading teams and advising federal clients in environmental policy. Utilize your extensive experience to manage complex challenges with a focus on collaboration...

Reimagine Regulatory Affairs by leading complex outsourcing programs and driving client success. Utilize deep expertise in strategy and operations to manage projects, mentor teams, and deliver tailore...

Champion regulatory strategies and submissions for global medical products, ensuring compliance across major markets while leading cross-functional teams and driving process improvements in a collabor...

Shape the future of regulatory strategy by leading projects that ensure compliance and market access. Drive collaboration across teams while managing processes for development and post-approval phases...

Provide comprehensive Regulatory Affairs support to ensure full compliance with U.S. FDA medical device regulations and international standards, facilitating product submissions and ongoing industry c...

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...

Unlock your potential in a dynamic role overseeing regulatory affairs for drug development. Collaborate cross-functionally to shape regulatory strategies and ensure compliance with global guidelines w...

Engage with cross-functional teams to ensure regulatory compliance for Expanded Access Programs. Drive essential strategies and submissions while staying aligned with global legislation, impacting pat...

Join an innovative team conducting vital research to enhance food safety. Contribute to developing analytical methods for detecting lead in food contact materials while collaborating with cross-functi...

Join an innovative team as a Clinical Affairs Specialist, where you'll develop strategies, improve processes, and ensure compliance in a dynamic, supportive environment dedicated to advancing clinical...

Lead the charge in transforming global regulatory strategies into successful outcomes. Oversee regulatory activities and empower teams to ensure quality compliance, timely delivery, and robust cross-f...

Join a team that's central to driving compliance in cosmetics and OTC products. You'll collaborate cross-functionally to support regulatory registration processes in the US and Canada, ensuring timely...

Elevate your career by leading global regulatory labeling strategies and initiatives. Oversee labeling governance, ensure compliance, and collaborate with cross-functional teams to support effective p...

Lead regulatory strategy for CAR-T and immunotherapy products, overseeing IND/IMPD and BLA submissions. Guide cross-functional teams, ensuring timely compliance and approvals while developing team mem...

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 passionate about advancing regulatory projects in the pharmaceutical industry. Drive compliance and ensure timely submissions while collaborating across functions, developing strate...

Shape the future of pharmaceutical quality research by conducting scientific analyses to evaluate protein drug stability and develop predictive methodologies that enhance regulatory decision-making fo...

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...

Champion validation excellence by leading initiatives in a GMP-regulated environment. Drive compliance, mentor teams, and ensure successful execution of qualification activities while supporting inspe...

Transform validation practices by leading robust qualification activities in a GMP environment, ensuring compliance with FDA and EMA regulations. Collaborate across teams to deliver excellence in vali...

Lead the charge in delivering strategic regulatory expertise and oversight for small-molecule drug development, ensuring compliance and supporting domestic manufacturing initiatives for essential gene...

Lead your career journey by supporting regulatory strategies, managing vital documentation, and ensuring compliance within the biopharmaceutical sector. Collaborate with health authorities while foste...