Senior Regulatory Affairs Specialist Jobs in Madison, NJ

Champion the administration and optimization of laboratory systems, ensuring seamless deployment, validation, and integration of informatics solutions within a GMP environment to enhance data integrit...

Manage clinical studies to ensure compliance with regulations and human subject protection. Coordinate site monitoring and maintain quality standards while communicating effectively with site teams to...

Deliver end-to-end bioprocess solutions by leveraging deep expertise in biopharmaceutical workflows, guiding complex customer collaborations, and driving high-impact project leadership for long-term s...

Join a team that's advancing nuclear engineering through component qualification, structural analysis, and seismic qualification for new and existing facilities. Collaborate with multidisciplinary exp...

Transform global regulatory processes by leading approvals, strategizing submissions, and ensuring compliance for medical devices across diverse markets while collaborating with teams and serving as a...

Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...

Lead the charge in ensuring top-notch inspection readiness across teams, managing quality metrics and overseeing audits. Drive continuous improvement and cultivate accountability within a dynamic phar...

Transform the quality management landscape by leading audits, managing cross-functional teams, and ensuring compliance with global regulations. Drive continuous improvement in quality processes and me...

Take ownership of driving revenue growth and market share through strategic account management and consultative selling in the histology consumables sector, cultivating relationships with laboratory a...

Drive impactful marketing campaigns through creative oversight and strategic management. Collaborate with cross-functional teams to enhance digital initiatives, optimize performance, and support organ...

Develop and validate statistical programs for clinical data analysis, collaborating with cross-functional teams to produce high-quality outputs that adhere to industry and regulatory standards through...

Unlock potential by driving strategic revenue growth in RTSM within global CRO partnerships. As an expert, you'll support sales strategies, potential deals, and amplify Medidata's market presence thro...

Optimize safety and compliance by championing industrial hygiene and biosafety initiatives. Lead technical projects while partnering across various teams to assess risks and implement compliant soluti...

Contribute to lead risk-based quality management for oncology trials across phases. Collaborate with cross-functional teams to assess risk, ensure data quality, and drive mitigation. Provide expert gu...

Optimize regulatory CMC strategies for antibody-drug conjugates and biologics, leading cross-functional teams to meet milestones in both development and post-approval phases while ensuring compliance...

Shape compliance strategies and lead regulatory efforts in cosmetics, ensuring adherence to global standards while managing a dedicated team in a dynamic environment. Drive innovation through collabor...

Join a dynamic team to lead global CMC regulatory strategies for biologics and ADCs. Drive regulatory milestones through product development and ensure compliance with international guidelines while c...

Join a dynamic team that drives innovative device characterization and design. Leverage advanced analytical tools to improve drug delivery technologies while showcasing your expertise in cross-functio...

Champion regulatory compliance by overseeing GXP applications and ensuring effective validation processes within high-stakes global pharmaceutical environments while leading diverse teams with minimal...

Champion the validation of biopharmaceutical systems, guiding teams through commissioning and qualification processes while ensuring compliance with regulatory standards and project timelines...

Tackle operational readiness within the expansion of a sterile drug manufacturing facility, ensuring compliance, collaboration, and efficiency. Lead equipment design, system qualification, and support...

Drive GMP training compliance and qualification programs within a cutting-edge biologics facility. Collaborate with cross-functional teams to develop curricula and manage training records, ensuring pe...

Manage quality oversight for drug-device combination products, ensuring compliance with global regulations and quality systems from development to commercialization. Collaborate with cross-functional...

Join a team that's driving compliance excellence in supply chain operations. This role blends collaboration across Contracts, Legal, and Supply Chain, focusing on government contracting and ensuring r...

Join a team that's dedicated to enhancing clinical trial quality through leadership, mentorship, and oversight. Engage remotely with cross-functional teams, driving high standards for patient safety a...