Regulatory Affairs Specialist Jobs in Frederick, MD

Unlock your potential as a Global Regulatory Leader, driving regulatory strategy and submissions for CNS projects. Collaborate with cross-functional teams, mentor junior staff, and ensure compliance w...

Lead the development and execution of global CMC regulatory strategies to support clinical trials and market applications, ensuring compliance with regulatory requirements throughout the product lifec...

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Drive strategic CMC regulatory leadership for late-stage and marketed products, ensuring compliance and quality in submissions. Collaborate with cross-functional teams to influence outcomes and engage...

Join a team that's shaping the future of military healthcare by providing expert regulatory guidance on drugs, biologics, and medical devices. Collaborate with cross-functional teams to develop strate...

Contribute to regulatory strategies for military-relevant drugs, biologics, and medical devices. Mentor teams, prepare submissions, and engage with FDA and other agencies to ensure compliance and opti...

Join a team that's driving innovation in R&D and Regulatory processes. Leverage your Veeva RIM expertise, manage global compliance systems, and implement solutions that meet dynamic business needs whi...

Drive regulatory strategy for military medical innovations, guiding product development and compliance for drugs, biologics, and devices. Collaborate with cross-functional teams to ensure successful s...

Champion regulatory excellence by leading cross-functional teams, ensuring compliance, and driving successful oncology drug development through strategic planning and expert guidance...

Champion global labeling strategy for innovative therapies, leading complex initiatives from development to post-approval. Collaborate with cross-functional teams to ensure compliance and high-quality...

Drive regulatory strategy across major programs, leading high-impact submissions and authority engagement. Collaborate with cross-functional teams to optimize clinical development and ensure complianc...

Unlock your potential by leading regulatory strategies for advertising and promotion. Collaborate with cross-functional teams to ensure compliance and drive successful commercialization initiatives in...

Empower your career by leading global regulatory strategies for medical devices and diagnostics. Collaborate with cross-functional teams to ensure compliance and drive market access while mentoring ot...

Join a team that's advancing regulatory strategies for drug substance manufacturing. Lead the charge in selecting and justifying Regulatory Starting Materials, ensuring compliance with global guidelin...

Drive quality assurance initiatives by auditing computer system validations and documentation. Collaborate with cross-functional teams to ensure compliance with regulatory standards while managing con...

Engage with government and regulatory bodies to shape automotive safety and technology policies. Lead communications, manage submissions, and foster collaboration across teams to ensure compliance and...

Unlock potential by leading regulatory writing for complex submissions, mentoring junior writers, and driving departmental initiatives. Collaborate with cross-functional teams to ensure compliance and...

Unlock potential by leading regulatory strategies for innovative medical devices. Collaborate with teams to ensure compliance, execute FDA submissions, manage project timelines, and establish processe...

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 performing advanced analytical testing and supporting quality review processes. Collaborate on method validation and continuous improvement initiatives to ensure product excellence...

Join a dynamic team to shape regulatory strategies and public policy initiatives, ensuring a favorable landscape for operations. Collaborate with stakeholders to protect investments and drive impactfu...

Join a team that's shaping regulatory strategies for advertising and promotion. Leverage your expertise to ensure compliance while collaborating with cross-functional teams to drive impactful product...

Lead regulatory compliance programs ensuring inspection readiness and proactive risk management across cross-functional teams. Monitor compliance health, manage data quality, and drive improvements al...

Champion quality systems and compliance in a global organization, ensuring regulatory readiness and customer support. Collaborate with stakeholders to maintain documentation and resolve complex qualit...

Shape the future of clinical trials by leading site monitoring efforts, ensuring compliance, and fostering collaboration across teams. Drive quality and efficiency in trial execution while mentoring j...