Regulatory Affairs Manager Jobs in Gaithersburg, MD

Lead global regulatory strategies for oncology programs, ensuring compliance and effectively interacting with regulatory agencies for product approvals in late-stage development...

Drive global trade compliance initiatives, ensuring adherence to U.S. regulations while fostering a cross-functional team environment. Lead efforts to implement strategies that align compliance practi...

Join and lead a dynamic team to ensure laboratory compliance with GLP and GCLP standards. Oversee quality assurance processes, manage staff performance, and drive continuous improvement initiatives in...

Optimize regulatory strategies for robotic surgical instruments, ensuring compliance and market access. Lead cross-functional teams, prepare vital submissions, and drive innovative product development...

Transform government pricing strategies by managing client relations and ensuring accurate federal drug price calculations while mentoring a team of analysts and providing expert guidance in complianc...

Provide regulatory expertise by preparing submissions, ensuring compliance, and collaborating with teams to maintain quality guidelines, supporting product development efforts and compliance with glob...

Innovate within Regulatory Affairs by leading AI-driven projects that transform digital processes, enhance strategic initiatives, and foster cross-functional collaboration for improved patient outcome...

Innovate food safety and quality assurance practices by managing supplier onboarding and regulatory compliance, enhancing operations through collaboration, education, and a positive safety culture to...

Join a team dedicated to ensuring drug quality compliance by performing data integrity audits, assessing adherence to FDA standards, and providing actionable recommendations to enhance regulatory deci...

Join a dynamic team to lead regulatory strategies, ensuring compliant promotional practices in pharma. Collaborate cross-functionally to guide materials review processes and implement innovative tacti...

Join our team to lead regulatory strategies across major programs, driving impactful submissions and fostering collaboration within a challenging and dynamic environment. Embrace the opportunity to in...

Empower innovation in quality compliance by overseeing GCP activities, conducting audits, managing regulatory inspections, and ensuring effective risk mitigation strategies throughout clinical develop...

Lead the development and execution of international regulatory programs, ensuring compliance with global financial regulations while driving effective stakeholder engagement and coordination across di...

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

Join a strategic leadership role that executes regulatory strategies globally, overseeing complex submissions and driving cross-functional collaboration to ensure successful market access and complian...

Contribute to regulatory excellence by coordinating U.S. submissions, ensuring compliance with FDA standards, and maintaining vital documentation for the Obesity Therapeutic Area, while collaborating...

Lead the charge in developing global regulatory strategies for clinical programs. Manage regulatory operations for product lifecycle while collaborating with cross-functional teams to ensure successfu...

Join a pivotal role in regulatory affairs, guiding promotional materials in compliance with FDA and provincial guidelines in a dynamic, remote environment. Lead the Materials Review Committee and shap...

Lead the charge in global regulatory strategies for innovative medical devices, driving project success from registration to compliance. Collaborate across teams to enhance healthcare technologies and...

Engage with a dynamic team to facilitate regulatory operations for novel therapeutics. Drive submissions to FDA/CVM while collaborating across multidisciplinary teams to set new regulatory standards i...

Elevate your career by mentoring a dynamic Regulatory Affairs team while driving compliance and strategic regulatory initiatives in the medical device industry. Make a substantial impact in global reg...

Join a team that's dedicated to advancing regulatory strategies for innovative SaMD products. Collaborate cross-functionally to drive compliance, manage documentation, and ensure readiness for audits...

Grow your career with a pivotal role ensuring regulatory compliance and strategic oversight for FDA submissions, while leading integrated project teams and driving innovative approaches to risk manage...

Partner with us to enhance quality systems and ensure compliance in a dynamic environment. This role encompasses internal audits, supplier quality management, and CAPA processes, driving continuous im...

Lead the charge in compliance management to enhance customer experience and ensure operational excellence in the alcohol category, collaborating cross-functionally to drive impactful programs and main...