Regulatory Affairs Manager Jobs in New Haven, CT

Lead our regulatory operations team in navigating UDI compliance and FDA regulations for medical devices, ensuring accurate registrations and supporting cross-functional initiatives that enhance produ...

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Champion compliance and innovation by advising cross-functional teams on FDA advertising regulations, driving strategic decisions to mitigate risks while supporting business objectives in healthcare c...

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...

Transform regional regulatory engagement by leading strategy, fostering relationships, and advocating for efficient electric transmission policies. Collaborate across departments to align regulatory g...

Tackle regulatory challenges by overseeing global quality compliance support, including managing audit logistics, controlled documents, training, and CAPA. Ensure adherence to quality standards while...

Take ownership of U.S. regulatory submissions, ensuring accuracy and compliance with FDA requirements. Collaborate cross-functionally to coordinate IND, NDA, and BLA filings, executing processes withi...

Unlock potential by leading global site activation for complex clinical trials. Drive strategy, manage cross-functional partnerships, and ensure compliance while fostering your team's growth in a fast...

Collaborate to lead regulatory projects, ensuring compliance with state and federal standards while enhancing internal processes and fostering strong stakeholder relationships for timely project compl...

Unlock the potential of Medical Affairs technology by driving Veeva CRM and Vault implementations, improving data management and AI workflows while collaborating with diverse stakeholders and deliveri...

Contribute to enterprise leadership in product safety risk management, ensuring compliance and aligned processes throughout the medical imaging software product lifecycle, and leading a team of safety...

Join us to ensure quality compliance and drive continuous improvement by overseeing global quality investigations, facilitating stakeholder interactions, and implementing corrective actions based on r...

Transform quality assurance processes by leading data analysis and compliance initiatives, and ensuring operational excellence in both Sterile and Non-Sterile Quality Operations to support product lau...

Champion regulatory excellence by leading global strategies for product approvals, collaborating with cross-functional teams and external experts to ensure compliance and drive successful commercializ...

Transform document management processes while ensuring compliance and accuracy. Collaborate with cross-functional teams to maintain regulatory standards and effectively oversee the distribution and ar...

Elevate quality standards as you lead QA/QM functions in sterile BFS manufacturing, ensure compliance with regulatory requirements, and drive continuous improvement initiatives while managing audits a...

Build impactful relationships with state healthcare regulators to enhance operational efficiency and compliance. Leverage consultative skills to drive multi-year contracts and strategic partnerships...

Lead early phase clinical trials, ensuring operational excellence and project delivery. Manage sponsor relationships, oversee project finances, and guide teams to successful execution in compliance wi...

Shape regulatory compliance strategies by overseeing "Grape to Bottle" and "Bottle to Market" frameworks. Collaborate with teams to ensure accurate reporting, streamline workflows, and support interna...

Lead the charge in establishing and maintaining quality standards, overseeing compliance, and driving continuous improvement in the quality assurance processes within a fast-paced pharmaceutical envir...

Lead compliance initiatives and provide strategic guidance on government contract accounting and regulations. Ensure adherence to DFAR, FAR, and CAS, while managing audits and supporting the organizat...

Lead regulatory initiatives and ensure compliance for nuclear projects, leveraging 5+ years of experience in licensing. Collaborate cross-functionally to drive complex projects and deliver effective d...

Drive impactful sales strategies, manage provider relationships, and spearhead growth initiatives for Rural Health Transformation while leading a dedicated team towards achieving ambitious healthcare...

Empower the digital transformation of global product development by leading the optimization of technology solutions that enhance protocol digitization and biospecimen management, ensuring high-qualit...

Collaborate with toxicology program leaders to oversee study design, execution, and data interpretation, ensuring adherence to safety protocols and operational goals. Drive excellence in study monitor...