- Merck & Co. (Durham, NC)
- Job DescriptionOur Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, ... the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, ... include but are not limited to;Project Support:Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp… more
- Merck & Co. (Durham, NC)
- …embraces an inclusive team culture including significant interaction with operations , quality, automation, technology, and other groups as required.Key ... HVAC, and/or multi-stage refrigeration systems).Required Experience and Skills:Familiarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral… more
- Merck & Co. (Durham, NC)
- …embraces an inclusive team culture including significant interaction with operations , quality, automation, technology, and other groups as required.Key ... cost savingsEducation Minimum Requirement:Bachelor Degree in Engineering, Science or an associate degree and 2 years experience in a production and/or calibration… more
- Sumitomo Pharma (Raleigh, NC)
- …coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission + Ensure compliance with ... is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused...highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The … more
- Parexel (Raleigh, NC)
- … requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the primary regulatory ... Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional… more
- GRAIL (Durham, NC)
- …other relevant documentation. The role collaborates cross-functionally with Quality, Lab Operations , and other stakeholders to support regulatory strategy ... For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal… more
- RxBenefits (Charlotte, NC)
- The Associate Counsel, Regulatory provides substantive support to the Legal Department, working primarily with the Regulatory team to monitor and advise on ... with federal, state, and local agencies. + Respond to regulatory agency inquiries + Providing legal support on various...and initiatives + Providing general legal support for company operations + All other duties as assigned _Required Skills… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …adherence to regulatory requirements. Oversees staff to ensure the efficient operations of the function. **Primary Responsibilities:** + As Global Regulatory ... than 110 countries and regions. **Summary:** Leads the R&D Regulatory Strategy group for assigned biologics products in managing...an equivalency could include 8 years of experience, an Associate 's degree with 6 years of experience, or a… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Job Summary** The Associate Director, Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and ... process design and governance practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA)… more
