- Constellation (Pottstown, PA)
- …Effective written and oral communication skills + Approval of VP Licensing & Regulatory Affairs required to obtain this classification (and recommendation of ... bonus and 401(k). **PRIMARY PURPOSE OF POSITION** Performs advanced regulatory /technical problem solving and provides analysis/insights in support of nuclear… more
- Organon & Co. (Plymouth Meeting, PA)
- …Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well as ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
- Cardinal Health (Harrisburg, PA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. More specifically, this role serves the function to support… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are ... Global Clinical Lead, Digital and AI reports directly to the Global VP, Clinical Affairs and collaborates closely with the leadership of Clinical Affairs to… more
- University of Pennsylvania (Philadelphia, PA)
- …Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision ... (CROs), and the FDA, as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Start-Up… more
- Sanofi Group (Swiftwater, PA)
- …products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. + Participate in Change Control assessment. + ... the future submission strategy; in collaboration with R&D functions, Industrial Affairs , Global Regulatory Affairs . + Coordinate the submission of CMC … more
- Sumitomo Pharma (Harrisburg, PA)
- …budget for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations, and Medical Affairs to ... submissions, clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with regulatory requirements. **Key… more
- Philadelphia Gas Works (Philadelphia, PA)
- …make impactful decisions within PGW low-income programs and grants + Assist customer affairs team in regulatory low-income customer reporting and transmittals + ... Work internally to maintain data updates in tracking files + Contribute ideas and propose solutions to improving current outreach and program effectiveness **Qualifications** + Currently enrolled in a Bachelor's degree in Business Administration, Public… more
- Penn Medicine (Philadelphia, PA)
- …This position works collaborativelywith the Patient Safety Officer, the Director of Regulatory Affairs and Accreditation, the Director of Infection Control, the ... to entity leaders. 5. In cooperation with Risk Management, Regulatory Affairs , and Infection Control, oversee the written disclosure to patients/families… more
- Bausch + Lomb (Harrisburg, PA)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
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