Senior Regulatory Affairs Specialist Jobs in Frederick, MD

Champion regulatory compliance by supporting quality processes and product lifecycle management in the medical device sector, ensuring adherence to standards during design, development, and commercial...

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...

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...

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...

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...

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...

Elevate regulatory compliance by analyzing drug quality databases, ensuring data integrity and FDA adherence. Collaborate with stakeholders to deliver actionable insights that enhance decision-making...

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...

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

Partner with us to lead global regulatory affairs for innovative pharmaceutical products. Oversee strategy, team development, and agency negotiations while ensuring compliance and operational excellen...

Lead critical clinical strategies and ensure regulatory compliance while collaborating across teams to uphold data integrity and support product development initiatives in a dynamic environment...

Shape the future of internal auditing by overseeing corporate compliance and quality assurance audits, driving improvements, and ensuring adherence to global regulations in a dynamic healthcare enviro...

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...

Optimize CMC regulatory strategies for biologic products across the product lifecycle. Lead cross-functional teams to ensure compliance with global regulatory standards while driving successful submis...

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...

Engage as a Global Regulatory Leader, driving innovative regulatory strategies and interactions to streamline product development and global approval processes, while ensuring compliance and effective...

Transform clinical trial management by maintaining essential documents and trackers, ensuring compliance with regulations, and supporting study teams throughout trial phases. Contribute to efficient o...

Join a team that's dedicated to ensuring quality through meticulous audits, root cause analysis, and regulatory compliance. Drive improvements in a GxP environment while mentoring peers and supporting...

Strategize impactful lifecycle regulatory strategies for radiopharmaceuticals, leading a global team to optimize compliance, drive submissions, and ensure seamless cross-functional collaboration while...

Transform the future of healthcare by leading regulatory strategies that accelerate innovative therapies for diverse clients. Join a dynamic team and shape the discourse in biopharma while enjoying fl...

Accelerate your impact by winning high-value, complex opportunities through innovative workflow design and technical expertise, while shaping market direction and influencing strategic commercial deci...

Shape the future of regulatory affairs by driving strategies for late-stage development programs. Collaborate across teams to ensure compliance, manage submissions, and support critical milestones in...

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 bioassay research and development for biotechnology products, focusing on assay validation and implementation. Collaborate on data-driven regulatory policies while managing research projects and...