Regulatory Affairs Specialist Jobs in Shepherdsville, KY

Accelerate regulatory strategy development for oncology products, leading global initiatives to secure IND/CTA approvals and marketing applications. Collaborate with cross-functional teams to navigate...

Lead global strategy for Notified Body engagement, ensuring compliance, managing audits, and driving certification readiness across various jurisdictions. Guide integration assessments, enhance proces...

Unlock your potential by overseeing site management and monitoring for clinical trials, ensuring compliance with regulations and enhancing site relationships to drive quality and timely delivery of cl...

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

Join a team that's dedicated to maintaining Good Clinical Practice and human subject protection. Oversee site monitoring, ensure compliance, and support clinical studies through effective communicatio...

Join a strategic role focusing on retaining and renewing high-value accounts, engaging with C-suite executives to enhance compliance value and ensuring optimal service delivery through consultative co...

Explore opportunities as a Clinical & Regulatory Information Management SME, supporting client delivery across VeevaRIM and Clinical initiatives. Engage with stakeholders, optimize processes, and enha...

Join a team that's dedicated to enhancing clinical trial quality through leadership, mentorship, and oversight. Engage remotely with cross-functional teams, driving high standards for patient safety a...

Drive quality assurance in GMP operations, ensuring compliance and product integrity while collaborating with internal and external stakeholders. Contribute to clinical manufacturing excellence throug...

Help us shape the future of clinical trials by providing regulatory guidance and maintaining compliance. Collaborate within cross-functional teams to ensure successful submissions and uphold industry...

Unlock potential in regulatory affairs by steering clinical trial submissions, ensuring compliance and strategic oversight. Collaborate with project teams, advising on regulatory pathways for successf...

Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...

Join a team that's driving quality compliance in clinical development. As a strategic leader, you'll oversee QMS effectiveness, risk management, and compliance initiatives, while partnering with stake...

Unlock potential by providing legal guidance for BaaS and payments initiatives, collaborating across teams to translate banking regulations into practical solutions, and ensuring compliance while fost...

Empower innovation in quality compliance by overseeing GCP activities, conducting audits, managing regulatory inspections, and ensuring effective risk mitigation strategies throughout clinical develop...

Shape the future of medical information by serving as a key expert in a dynamic role that combines your scientific expertise with technology and content development to ensure high-quality responses fo...

Drive impactful medical writing by leading regulatory documentation projects, ensuring clarity and compliance with standards, while collaborating across teams to deliver exceptional results and foster...

Empower regulatory compliance within the 340B Program by interpreting complex regulations, advising internal teams, and ensuring operational readiness. Drive impactful educational initiatives and coll...

Unlock potential by supporting project compliance tracking and permitting functions. Collaborate with agencies to ensure adherence to regulations while managing documentation and communication for con...

Unlock potential as you drive US market access strategy, ensuring effective payer and provider engagement while leading reimbursement initiatives and enhancing patient access outcomes across the healt...

Innovate global CMC regulatory strategies and submissions for biological products. Ensure high-quality compliance with US and Canadian regulations, while collaborating cross-functionally to manage lif...

Transform government pricing strategies by managing client relations and ensuring accurate federal drug price calculations while mentoring a team of analysts and providing expert guidance in complianc...

Drive impactful marketing campaigns through creative oversight and strategic management. Collaborate with cross-functional teams to enhance digital initiatives, optimize performance, and support organ...

Unlock your potential as a key leader in GxP auditing, driving compliance and quality oversight across computerized systems in regulated environments. Collaborate cross-functionally to enhance risk ma...

Transform quality standards in medical devices by leveraging 5+ years of expertise in validation and engineering. Collaborate cross-functionally to enhance compliance, drive continuous improvement, an...