- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …assigned project teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary ... all CMC and GMP related documents for submission to regulatory authorities to assure compliance with ...programs (Word, Excel, PowerPoint, and Outlook). + 7-years CMC regulatory experience in the pharmaceutical industry with… more
- Grifols Shared Services North America, Inc (Atlantic Beach, NC)
- …Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral ... Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write… more
- Sumitomo Pharma (Raleigh, NC)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Manager , Compliance , Training & Strategic Alliance (CTSA), PVRM** . The ... Associate Manager , Compliance , Training & Strategic Alliance (CTSA),...- 3 years of relevant experience in biotech or pharmaceutical industry specific to Pharmacovigilance operations and compliance… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas ... complex submissions to various governmental agencies and ensure contents are in compliance with domestic and international regulatory requirements. + Prepare… more
- United Therapeutics (Raleigh, NC)
- …culture of compliance with confidence and enthusiasm. The Senior Corporate Compliance Manager - Training, Communications and Policy will be responsible for: ... training and communication Minimum Requirements + 10+ years of experience in compliance in the life sciences industry: pharmaceutical , medical or biotech with… more
- Fujifilm (Morrisville, NC)
- **Position Overview** The Senior Manager , Quality Compliance is responsible for the day-to-day activities of the Pharmaceutical Quality Systems (PQS) team ... including learning set up for PQS, including global processes + Interfaces with Regulatory Affairs and BPOs to develop robust compliance processes, implements… more
- ThermoFisher Scientific (Wilmington, NC)
- …Office **Job Description** Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance Oversight Manager and play a crucial role in ensuring the ... team functional representatives. + Plan, monitor, and report on quality and compliance for selected clinical trial delivery processes to determine adherence to and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …inventory of pharmaceutical samples to field representatives. + Ensure compliance with regulatory tracking and reconciliation requirements. + Coordinate with ... **Position Summary** The Senior Manager , Fleet & Samples Operations oversees the execution...field support or commercial operations teams. + Knowledge of compliance requirements related to pharmaceutical samples. **Preferred:**… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- … pharmaceutical company. POSITION SUMMARY: Under the direction of the Senior Manager , Quality Compliance , the Quality Compliance Specialist is responsible ... Quality Compliance Specialist Department: Quality Location: Monroe, NC START...manner. This position will also provide site representation for regulatory surveillance program. JOB RESPONSIBILITIES: Financial: Provide support in… more
- Eurofins (Raleigh, NC)
- Eurofins is the world leader in the bio/ pharmaceutical testing market. With over €6.5 billion in annual revenues and 62,000 employees across 900 sites in 62 ... Product Testing (BPT) Group is the largest network of harmonized bio/ pharmaceutical GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive… more