- Deloitte (Philadelphia, PA)
- Senior Manager - FSI Risk, Regulatory & Forensic Our Deloitte Regulatory , Risk & Forensic team helps client leaders translate multifaceted risk and an evolving ... regulatory environment into defensible actions that strengthen, protect, and...will craft solutions for clients, guide and oversee the quality of your team's deliverables and recommendations and manage… more
- Organon & Co. (Plymouth Meeting, PA)
- …project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on ... Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role...or device operations (eg, manufacturing, process development, analytical, and quality assurance) is required. + At least five years… more
- IQVIA (Wayne, PA)
- …projects with a regulatory component, and ensure we provide consistently high quality insights and content + Support billable projects as SME and/or study lead, ... The Head of the Center of Excellence (CoE) for Regulatory Strategy sits within the COA consulting business of...and oversight to upskill team and ensure consistent high quality consulting and written deliverables + Participate in annual… more
- J&J Family of Companies (West Chester, PA)
- …with the Innovation leaders: Global Strategic Marketing, New Business Development, R&D, Regulatory , Clinical, Quality , & Supply Chain leveraging deep medical ... closely with R&D Teams and life-cycle management, including management of regulatory documents, critical evaluation of clinical risk and input regarding potential… more
- Bausch + Lomb (Harrisburg, PA)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/Device ... ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...manage and monitor study related expenses to meet forecast. Regulatory Reports: + Provide Clinical Operations support in the… more
- Fresenius Medical Center (Philadelphia, PA)
- …** QUALITY :** + Responsible for supporting and driving organization quality standards through meeting regulatory and accrediting body requirements ... Adheres to the Organization Compliance Program, including following all regulatory and Organization policy requirements. Provides direct nursing care...and the practice of Continuous Quality Improvement (CQI), including use of CQI tools. +… more
- Sanofi Group (Swiftwater, PA)
- **R2814855 Regulatory Site Office Manager** **Location:** Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks ... and bring hope to patients and their families. The Regulatory Site Office Manager, Vaccines will work closely with...a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least… more
- Chemours (Harrisburg, PA)
- …electronics, high-performance computing and AI, climate friendly cooling, and high- quality paints and coatings for homes and industrial infrastructure sustainable ... modern living depend on Chemours chemistry. Chemours is seeking a **Director of Regulatory Advocacy** to join our growing Government Affairs team! This position will… more
- Penn Medicine (Philadelphia, PA)
- …Director of Pharmacy and the Outpatient Pharmacy Managers, the Ambulatory Regulatory Technician assists the Managers in the evaluation, reporting and monitoring ... of all aspects pertaining to pharmacy payer audits and regulatory compliance. + The Ambulatory Regulatory Technician is responsible for helping to manage the… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more