Regulatory Affairs Specialist Jobs

Take ownership of capital projects in ophthalmic drug manufacturing. Lead cross-functional teams to deliver integrated plans for cleanroom and facility upgrades while ensuring compliance with GMP and...

Deliver technical expertise in sterile product manufacturing, ensuring process validation, compliance, and troubleshooting to meet FDA/EU standards. Collaborate across teams to drive efficient product...

Elevate your career by leading innovative QC projects, collaborating with teams, conducting advanced analytical testing, and ensuring compliance while training fellow scientists in a supportive, fast...

Join a dynamic team as you drive sales success by providing expert technical guidance on cell and gene therapy applications, enhancing product innovation while ensuring clients receive tailored soluti...

Support the Federal Government Affairs team by developing strategies that advance healthcare access and reimbursement. Engage with Congress to influence policy and optimize processes, ensuring impactf...

Advance your career as you lead environmental permitting and grants management for coastal infrastructure projects, ensuring compliance and driving funding success through strategic stakeholder engage...

Drive federal acquisition initiatives by leading a skilled team, ensuring compliance, and delivering strategic insights for contract development and oversight across all acquisition types. Your expert...

Unlock potential by providing engineering support for non-sterile operations, ensuring compliance with GMP while optimizing equipment and facilities to meet clinical needs in a fast-paced, shift-based...

Lead innovative engineering efforts at two manufacturing sites, enhancing sterile drug product capacity. Engage in troubleshooting, support quality operations, and collaborate with cross-functional te...

Shape the future of sterile clinical manufacturing by providing technical expertise in formulation, process development, and equipment maintenance to ensure GMP compliance and operational excellence a...

Manage the life-cycle of OSD records, ensuring compliance with federal regulations and optimal archival strategies while leading a team in records management initiatives and policy developments...

Manage the complete lifecycle of OSD records, ensuring compliance with federal regulations while leading program planning, records evaluations, and support for electronic records systems in a fast-pac...

Champion OSD records management lifecycle, ensuring compliance and accuracy while leading strategic initiatives for digital transition and efficient documentation processes in alignment with federal r...

Oversee reactor licensing initiatives, ensuring compliance with regulatory strategies for military and commercial applications of advanced nuclear technology. Collaborate cross-functionally on deliver...

Lead the charge in executing risk-based audits and enhancing AbbVie’s compliance environment while fostering stakeholder engagement and team development through a culture of collaboration and trust...

Analyze and execute compliance audits while collaborating with stakeholders to enhance internal controls and mitigate risks. Contribute to the development of team skills in a dynamic, supportive cultu...

Lead and optimize quality initiatives as a key driver in ensuring compliance and customer satisfaction. Partner with diverse teams to enhance quality standards and implement improvements across all op...

Drive innovative biologics purification processes, collaborating with teams to enhance drug discovery and deliver high-quality therapeutic candidates for transformative patient care...

Lead a small team in Analytical R&D to establish and execute Process Analytical Technology (PAT) strategies. Drive multidisciplinary efforts to support drug substance and product development, ensuring...

Shape procurement management for strategic space programs by serving as the key Supply Chain liaison. Engage with buyers, suppliers, and technical teams to ensure execution of complex projects while m...

Contribute to strategic supply chain management for complex aerospace programs. This role ensures timely procurement execution, supplier engagement, and detailed schedule tracking, acting as a liaison...

Lead the charge in overseeing clinical studies to enhance organ preservation through innovative research and management strategies, ensuring compliance and data integrity across multiple protocols and...

Manage regulatory reporting and compliance for environmental projects. Lead implementation of the Environmental Management System and engage with stakeholders to ensure adherence to legislation while...

Deliver administrative leadership for regulatory services in clinical trials. Manage compliance with regulations, oversee staff development, and ensure effective processes for regulatory submissions...

Drive maintenance excellence by coaching, mentoring, and coordinating technician teams to enhance production quality and efficiency while fostering a culture of continuous improvement...