Director, Regulatory Affairs Jobs in Shepherdsville, KY

Unlock potential by driving regulatory submissions and managing documentation. Collaborate with global teams to align on strategies, ensuring compliance and effective communication while fostering a c...

Drive global regulatory labeling initiatives, ensuring compliance and quality of documentation across diverse markets. Lead strategic governance, influence policies, and collaborate cross-functionally...

Collaborate with cross-functional teams to oversee regulatory activities for a portfolio of Pharmaceutical Diagnostics products, ensuring compliance and strategic alignment with global standards throu...

Lead the charge in providing technical stewardship and support for the manufacturing science of oncology and neurology oral solid products, ensuring compliance with regulatory standards across global...

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

Take ownership of a comprehensive compliance program, ensuring regulatory readiness and effective oversight across multiple states in telehealth. Lead a team dedicated to establishing policies and fos...

Drive operational excellence by leading a dynamic team overseeing external manufacturing operations. Collaborate with global partners to enhance drug substance, product quality, and continuity while f...

Transform the biopharmaceutical landscape by advising clients on regulatory compliance and clinical pharmacology strategies, leveraging your expertise to impact innovative drug development across dive...

Join a team dedicated to ensuring drug quality compliance by performing data integrity audits, assessing adherence to FDA standards, and providing actionable recommendations to enhance regulatory deci...

Manage regulatory submissions and compliance for medical devices. Collaborate across departments to ensure adherence to standards, support audits, and maintain quality throughout clinical processes an...

Drive growth and customer success by leading consultative sales for CDMO solutions in the pharma sector. Build executive-level relationships and deliver tailored manufacturing support from concept to...

Provide regulatory expertise by preparing submissions, ensuring compliance, and collaborating with teams to maintain quality guidelines, supporting product development efforts and compliance with glob...

Elevate the regulatory landscape by guiding strategic promotional communications for Oncology products. Shape impactful messaging while ensuring compliance and aligning with evolving regulations and F...

Elevate your career by leading compliance and quality in clinical trials. Collaborate with teams to ensure protocol adherence, site training, and resolve issues while maintaining high standards of mon...

Tackle clinical monitoring challenges while leading site initiatives for quality compliance and protocol adherence. Collaborate with cross-functional teams to ensure successful clinical trial executio...

Optimize your clinical research career by playing a vital role in overseeing and conducting site monitoring for clinical trials, ensuring compliance, quality, and effective team collaboration througho...

Unlock potential by leading site monitoring for clinical trials. Collaborate closely with cross-functional teams to ensure compliance, enhance recruitment, and oversee execution while providing guidan...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

Join our team to lead regulatory strategies across major programs, driving impactful submissions and fostering collaboration within a challenging and dynamic environment. Embrace the opportunity to in...

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...

Lead the charge in global Pharmacovigilance Operations, ensuring strategic compliance, operational excellence, and inspection readiness to support product growth and regulatory success in a dynamic en...

Oversee the healthcare compliance program, ensuring adherence to regulations and policies while conducting investigations, training, and audits to mitigate risks and enhance transparency across client...

Bring your expertise to a dynamic team as you lead high-impact medical content development. Collaborate cross-functionally, mentor talent, and strategize with clients to enhance medical education and...

Oversee promotional material reviews and ensure regulatory compliance in the pharmaceutical sector. Collaborate with cross-functional teams to align business objectives with FDA regulations, driving i...

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...