Regulatory Affairs Specialist Jobs in Durham, NC

Serve as a strategic regulatory leader, guiding nonclinical drug development and ensuring compliance for successful clinical entry and regulatory submissions, collaborating with cross-functional teams...

Lead by unlocking potential through validation services, ensuring successful IT & Automation project delivery, maintaining compliance, and driving process improvements in a collaborative, regulated en...

Champion regulatory excellence by leading postmarket strategies for product compliance, driving collaboration across teams to ensure timely submissions and navigate complex regulatory landscapes for c...

Join a dynamic team as a Senior Specialist, Quality Engineer, providing critical oversight in GMP operations at a leading biopharmaceutical facility, ensuring compliance, audit readiness, and quality...

Transform compliance through expertise in HR regulations, policy management, and training. Support a culture of accountability while navigating multi-state employment laws across diverse teams, ensuri...

Lead global regulatory strategies for oncology programs, ensuring compliance and effectively interacting with regulatory agencies for product approvals in late-stage development...

Unlock the power of regulatory insights! Lead comprehensive monitoring and analysis of regulatory developments, providing actionable intelligence to guide business strategy and decision-making across...

Innovate robust global regulatory frameworks to enhance compliance, drive quality initiatives, and support strategic goals across diverse teams while ensuring adherence to international standards and...

Join a pivotal role in regulatory affairs, guiding promotional materials in compliance with FDA and provincial guidelines in a dynamic, remote environment. Lead the Materials Review Committee and shap...

Transform and lead strategic quality compliance initiatives, implementing risk-based practices to ensure operational excellence and regulatory adherence in a dynamic manufacturing environment. Drive c...

Empower global product strategy in Regulatory Affairs, leading teams to navigate complex regulations for therapeutic developments in inflammation and rare diseases. Drive global registration and lifec...

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...

Lead the charge in audit compliance by ensuring quality standards are met, managing teams, and driving continuous improvement across audit responses and documentation. Collaborate with clients to miti...

Join as a Clinical Research Associate to oversee critical monitoring tasks across diverse clinical studies. Ensure high-quality standards while facilitating communication between project teams and sit...

Engage in critical monitoring tasks for diverse clinical studies, ensuring compliance and quality while communicating effectively with project teams and site staff to meet recruitment targets and main...

Advance regulatory strategies and oversight for global clinical trials. Support submission preparation, manage CRO interactions, and collaborate cross-functionally to navigate regulatory challenges an...

Drive supplier quality oversight and compliance in GMP manufacturing, ensuring rigorous supplier assessments, audits, and risk management while collaborating with cross-functional teams to enhance man...

Lead the charge in NERC compliance oversight, supporting member audits and program reviews while monitoring regulatory changes to enhance compliance strategies and efficiency across internal workgroup...

Transform regulatory writing by leading complex submissions, mentoring teams, and ensuring compliance. Drive innovation and improve processes while collaborating across teams to enhance product succes...

Innovate the future of regulatory labeling by driving strategies across global teams, ensuring compliance and quality at all stages of product development while collaborating with key stakeholders to...

Drive global CMC regulatory strategies and submissions for clinical and commercial products. Collaborate cross-functionally to ensure compliance, lifecycle management, and timely delivery of high-qual...

Lead the charge in shaping and executing the Regulatory Information Management strategy, ensuring data governance and compliance while fostering team development and cross-functional collaboration to...

Unlock potential by leading quality compliance initiatives and audits, ensuring regulatory adherence. Drive improvement projects while managing operational tasks. Collaborate across teams to ensure ex...

Unlock potential by leading regulatory submissions strategy and excellence across global clinical trials, ensuring compliance and timely approvals while managing risks and aligning with project teams...

Transform compliance practices by leading structured reviews for federal health programs. Utilize strong judgment and analytical skills to ensure adherence to requirements and maintain documentation...