Regulatory Affairs Specialist Jobs in Gaithersburg, MD

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

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...

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...

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...

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

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...

Contribute to safety and compliance by ensuring thorough processing of adverse event reports and conducting medical evaluations, while supporting clinical research and adhering to regulatory standards...

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...

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...

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...

Transform federal regulatory projects by leading execution, managing schedules, and collaborating with stakeholders. Drive efficiency and quality through expert coordination, risk monitoring, and stra...

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...

Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...

Take ownership of regulatory affairs operations, leading teams to enhance processes within clinical trials while ensuring compliance with regulations and fostering collaboration across departments...

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

Shape the future of patient access by leveraging regulatory strategy expertise to guide pharmaceutical clients in navigating complex regulatory landscapes and developing innovative access solutions fo...

Tackle compliance oversight through detailed assessments, reporting, and collaboration with law enforcement partners to ensure program adherence and address deficiencies efficiently across a high-volu...

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...

Lead the charge in clinical research by monitoring studies across various therapeutic areas, ensuring top-quality standards and effective communication with stakeholders while driving project timeline...

Help us drive excellence in clinical research by monitoring studies across various therapeutic areas, enhancing collaboration with project teams and trial sites, and ensuring adherence to the highest...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Advance your career by leading regulatory writing initiatives for vital U.S. tobacco submissions. Collaborate with global teams to ensure regulatory compliance and clear communication, driving key pro...

Help us ensure compliance by providing regulatory guidance and risk assessments for promotional materials in the pharmaceutical industry. Collaborate across teams to implement innovative strategies an...