Regulatory Affairs Manager Jobs in Gaithersburg, MD

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...

Lead the charge in ensuring regulatory compliance globally for Expanded Access Programs, enhancing patient access to innovative therapies through collaboration across diverse teams while maintaining q...

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...

Oversee regulatory submissions and lead strategic planning efforts, ensuring efficient navigation through complex approval processes. Collaborate with diverse teams to secure quality outcomes in a fas...

Innovate and execute regulatory CMC strategies for radiopharmaceutical products, ensuring compliance across global markets. Collaborate with cross-functional teams to support submissions and enhance p...

Lead impactful initiatives in regulatory affairs within the chemical and environmental sectors. Collaborate with stakeholders, monitor policies, and communicate client priorities effectively to naviga...

Lead the charge in regulatory strategy for clinical studies, providing expert guidance on complex global compliance. Drive communication with health authorities and ensure timely documentation while c...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

Take ownership of regulatory affairs projects, ensuring timely submissions and adherence to quality standards. Lead cross-functional teams, enhance processes, and manage budgets while navigating the c...

Elevate global regulatory strategies within drug development, leveraging your expertise to enhance collaboration and impact. Lead cross-functional teams, guiding products from conception to market rel...

Pioneer regulatory strategies and drive drug development, managing complexities in compliance and lifecycle activities for groundbreaking therapies. Collaborate with diverse teams to influence health...

Drive global quality compliance initiatives by leading audits and ensuring regulatory adherence across various facilities and stakeholders. Champion compliance risk identification and resolution while...

Join a team that's shaping regulatory strategies in biopharmaceuticals. This role involves leading regulatory submissions and collaborating across project teams to ensure compliance while advancing co...

Launch your career by supporting regulatory submissions and compliance activities, coordinating documentation, and engaging in team collaborations to drive successful outcomes in drug development and...

Tackle complex regulatory challenges in advertising and promotion within the immunology field. As a Senior Manager, you will lead a team to ensure compliance with legislation while influencing the reg...

Shape your future by leading regulatory strategies for advertising and promotion in Immunology. Collaborate across teams and mentor regulatory professionals while ensuring compliance with evolving reg...

Pioneer regulatory excellence by leading FDA submissions and compliance. Manage the lifecycle of medical product filings, ensuring alignment with evolving regulations across diverse jurisdictions in a...

Join a dynamic team to shape regulatory strategies for global product registrations, ensuring compliance with diverse international requirements while collaborating with cross-functional stakeholders...

Support cross-functional teams by providing regulatory guidance for IVD product development, developing strategies, and conducting risk assessments to ensure compliance with FDA and EU regulations for...

Champion global regulatory activities, ensuring high-quality submissions and strategic partnerships. Support lifecycle management across late-stage development, driving compliance with U.S. and intern...

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 the Regulatory Intelligence function, ensuring seamless regulatory compliance, strategic insights, and operational excellence across diverse programs and markets. Guide stakeholders by devel...

Champion regulatory excellence by coordinating global product registrations, interpreting complex regulations, and collaborating with cross-functional teams to ensure compliance and quality for intern...

Lead the establishment of a robust Product Quality function, enhancing governance and processes for evaluating lending products to ensure compliance, reliability, and accuracy across the financial ser...

Advance your expertise by leading regulatory strategies for innovative products targeting rare diseases, ensuring successful registrations and long-term lifecycle management. Collaborate with cross-fu...