Senior Regulatory Affairs Specialist Jobs in Madison, NJ

Oversee the healthcare compliance program, ensuring adherence to regulations and policies while conducting investigations, training, and audits to mitigate risks and enhance transparency across client...

Drive innovative intellectual property strategies for cutting-edge biosimilars, focusing on freedom-to-operate and patent litigation support while collaborating with cross-functional teams to shape th...

Serve as the strategic leader in product safety, ensuring proactive risk management and compliance for marketed and developmental oncology products while driving efficiency and best practices across g...

Create efficiencies in contract management by partnering with stakeholders to negotiate and manage procurement agreements while mitigating risks and enhancing business operations. Enjoy broad exposure...

Lead the charge in shaping product safety strategy and risk management, overseeing medical safety efforts across the product lifecycle, and collaborating with multiple stakeholders to ensure complianc...

Shape the future of digital transformation by leading systems engineering initiatives to modernize and enhance Coast Guard operations, bridging the gap between technology and mission-critical requirem...

Drive successful technology transfer and project management in advanced therapies, collaborating with internal teams and CDMOs. Contribute to operational excellence by leading cross-functional efforts...

Elevate your career by joining our global R&D audit team, where you will lead and participate in GCP compliance audits. Contribute to process improvements and enhance clinical trial quality, impacting...

Engage in the development and quality control of clinical documents, ensuring compliance with regulatory standards while managing projects and fostering team collaboration for successful submissions...

Join our team to provide strategic legal support for R&D activities across the Americas, focusing on innovative medicines and ensuring compliance with regulatory requirements. Help navigate complex le...

Transform manufacturing processes by providing technical leadership for cGMP operations. Drive technology transfer, process validation, and continuous improvement to ensure high-quality therapies, sup...

Join a pioneering team to lead medical strategy in oncology, influencing mRNA programs from development through commercialization, ensuring cross-functional alignment and stakeholder engagement to dri...

Drive safety surveillance for clinical trials, ensuring compliance and quality case management. Contribute to risk management across respiratory therapeutics while collaborating with cross-functional...

Transform technology product strategies for clinical trials, ensuring protocol digitization and biospecimen management excellence. Lead a dynamic team while collaborating with diverse stakeholders to...

Drive compliance strategy by managing IL4/IL5 offerings, ensuring regulatory adherence across AWS-hosted environments. Collaborate with security teams, federal regulators, and technical stakeholders t...

Shape the future of intellectual property protection in bioprocessing. In this role, you will collaborate with scientists and lead patent activities, ensuring robust management and strategic developme...

Drive validation excellence in a GMP-regulated environment, ensuring compliance and quality by executing rigorous validation protocols and collaborating with cross-functional teams to enhance process...

Unlock potential by providing expert legal counsel on employment law issues. Partner with various teams to drive legal strategies, ensure compliance, and mitigate risks while supporting mergers, acqui...

Champion the oversight of QC activities in gene therapy, ensuring compliance and operational excellence across external testing labs while collaborating with cross-functional teams to drive innovation...

Join us to enhance quality systems, support team activities, and strengthen documentation processes. Your expertise will drive collaboration and alignment across local and global initiatives while ens...

Lead customer enablement for North America OEM accounts, ensuring satisfaction and operational excellence. Oversee issue resolution, process improvements, and cross-team collaboration to drive revenue...

Lead comprehensive risk assessments and quality governance for aseptic manufacturing, ensuring compliance with regulatory standards and enhancing contamination control strategies within global facilit...

Support risk assessment and quality governance in aseptic manufacturing, ensuring compliance with regulations. Collaborate with cross-functional teams to establish and maintain design standards for fa...

Join a team that's shaping the future of aseptic quality by overseeing design, risk assessments, and regulatory compliance for facilities and utilities in a pharmaceutical environment, ensuring optima...

Optimize procurement strategies by managing supplier relationships, sourcing initiatives, and material availability to enhance production efficiency. Utilize your expertise to drive cost improvements...