- Chiesi (Cary, NC)
- Global Regulatory Affairs Labeling & Promotional Manager Date: Jan 23, 2025 Department: Global Regulatory Affairs Job Type: Direct Employee ... external departments and health authorities as needed in the activities of the Global Regulatory Affairs group. + Provide input to support trial designs… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …US and EU standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team ... Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory...Labeling cross functional teams including clinical, safety, medical affairs , device regulatory and commercial, to ensure… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …Escalation Process and Stakeholder Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and ... Labeling cross functional teams including clinical, safety, medical affairs , and commercial, to ensure the highest level of... Team and GRA + Represents Global Labeling at Global Regulatory Team… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …success._ Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) Manager of Regulatory Affairs , the Specialist of Regulatory Affairs ... expertise to MMS-PA platform. This individual facilitates the regulatory affairs activities within the MMS-PA platform.... Product Development System (GPDS) + Serves as a regulatory expert for labeling and promotional materials… more
- Sumitomo Pharma (Raleigh, NC)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Chiesi (Cary, NC)
- …the Medical Affairs Respiratory Team, providing medical input on US labeling and regulatory interactions. + Collaborates with clinical operations and teams ... to lead the development, execution, and implementation of the global Medical Affairs strategy for Seralutinib within...ensuring the strategy effectively addresses the distinct needs and regulatory landscapes of both the US and ROW markets.… more
- Fujifilm (Raleigh, NC)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more… more