Regulatory Affairs Specialist Jobs in Wooster, OH

Lead end-to-end GCP audits globally, ensuring compliance and driving improvements in clinical studies. Collaborate with stakeholders to interpret regulations and support regulatory inspections in a dy...

Drive your career forward by leading regulatory labeling and compliance strategies in a dynamic role that collaborates across teams to ensure successful product lifecycle management and adherence to i...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Lead the development of global regulatory strategies and ensure compliance throughout the product lifecycle, from pre-approval to post-approval, as a strategic partner and advisor to cross-functional...

Lead the development and execution of global CMC regulatory strategies, ensuring compliance from discovery through commercialization. Collaborate with cross-functional teams to address regulatory requ...

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...

Lead the charge in compliance strategy for U.S. Commercial and Market Access. Collaborate with senior leaders to guide complex compliance issues, manage risks, and support innovative business objectiv...

Shape the future of regulatory submissions by ensuring high-quality QC reviews of clinical documents. Collaborate with global teams to meet project timelines while maintaining compliance with industry...

Join a team that's shaping healthcare through innovative legal counsel. You'll oversee commercial contracting, guide compliance, and streamline legal operations for critical partnerships in health sys...

Lead the charge in ensuring continuous regulatory compliance and inspection readiness for R&D technology solutions by executing audit readiness strategies, embedding GxP compliance, and collaborating...

Manage clinical studies to ensure compliance with regulations and human subject protection. Coordinate site monitoring and maintain quality standards while communicating effectively with site teams to...

Join a team that's committed to ensuring compliance and accountability in construction by performing detailed audits of payment applications, guiding project owners, and fostering best practices acros...

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...

Unlock potential by leading regulatory strategy for clinical gene therapy programs. This execution-focused role drives submissions and health authority interactions while collaborating across cross-fu...

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...

Contribute to lead risk-based quality management for oncology trials across phases. Collaborate with cross-functional teams to assess risk, ensure data quality, and drive mitigation. Provide expert gu...

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...

Lead the high-quality monitoring of clinical trials, ensuring compliance with regulatory standards while managing site operations, training staff, and protecting participant safety in a fast-paced, dy...

Lead process development and validation in medical device R&D. Drive complex projects, mentor teammates, and utilize advanced statistics to enhance products from research to implementation. Collaborat...

Drive clinical excellence by overseeing site management and monitoring for biotech and pharmaceutical projects, ensuring compliance and accuracy in clinical research data. Join us to impact lives thro...

Champion the creation of high-quality regulatory documents, managing writing tasks and leading reviews. Collaborate across teams to ensure clarity and compliance, mentoring junior writers while delive...

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...

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