Senior Regulatory Affairs Specialist Jobs in Durham, NC

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

Lead quality assurance initiatives to ensure compliance and operational excellence in sterile drug manufacturing. Collaborate cross-functionally to embed quality standards and drive continuous improve...

Join a team that's dedicated to ensuring compliance and quality in laboratory digital systems. Oversee the lifecycle management of LIMS and analytical platforms, translating business needs into compli...

Manage regulatory activities for advertising and promotion, ensuring compliance while collaborating with cross-functional teams to develop impactful product messaging and materials that align with com...

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

Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...

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...

Transform compliance standards by leading site inspections and audit readiness. Drive a robust Quality Culture, ensuring continuous improvement and operational excellence in aseptic drug product manuf...

Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...

Unlock your potential as a regulatory leader, driving CMC strategies and ensuring compliance at a key manufacturing site. Collaborate globally to navigate complex regulatory landscapes and support inn...

Empower your career by leading regulatory advertising initiatives, ensuring compliance while collaborating with cross-functional teams to develop impactful product messaging for marketed and pipeline...

Join a team that's dedicated to ensuring vaccine quality and safety by overseeing compliance and operational excellence in aseptic manufacturing processes. Collaborate with experts and CMOs to drive c...

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

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 potential by leading regulatory compliance for IVD products, ensuring adherence to global standards. Collaborate with cross-functional teams to assess risks, manage adverse events, and drive co...

Join a global team to shape regulatory strategies in biotechnology, supporting product development and lifecycle management in Inflammation and Rare Diseases. Lead regulatory efforts, ensure complianc...

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 your potential in regulatory affairs, supporting drug, biologic, and device projects. Collaborate with teams, prepare key documents, and engage with health authorities to ensure compliance and...

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...

Join a dynamic team as you manage complex commercial contracts, balancing legal and business needs. Collaborate with cross-functional stakeholders to drive negotiations and enhance contracting process...

Advance your career by leading clinical research projects and ensuring compliance with timelines and standards. Collaborate with stakeholders and clinical sites to safeguard subjects' rights and data...

Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...

Champion the successful implementation of RTSM systems, ensuring timely delivery and adherence to client requirements while managing project budgets and communications throughout the project lifecycle...

Champion regulatory excellence by leading CMC strategies for small molecule programs, ensuring compliance and driving successful submissions from early development through commercialization in a dynam...