- Chiesi (Cary, NC)
- …reviewers/approvers to get content approved to support business needs + Ensures regulatory compliance while effectively managing business risks + Understands ... and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing...guidance documents and initiating changes in systems to ensure regulatory compliance . Knowledge of Common Technical Document… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …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 of, and leads/executes regulatory strategy and tactical decisions… more
- ThermoFisher Scientific (Greenville, NC)
- …Description** **Job Description** Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance Oversight Manager and play a crucial role in ensuring the ... understanding on evaluated processes. **Requirements** + Bachelor's degree preferred + Regulatory Authority Inspections Experience ( FDA , MHRA, HEALTH CANAD,… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …candidate will possess deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch ... design SAP BRH solutions that optimize batch release processes. ** Regulatory Compliance :** + Ensure that all SAP...comply with relevant Life Sciences industry regulations, including GxP, FDA , EMA, and other regulatory bodies. +… more
- ALBEMARLE (Charlotte, NC)
- … Regulatory , Hazard Communication and Toxicology staff. This leader will ensure regulatory compliance , and the safety of the products placed into the ... regulatory programs, such as: Canada, Mexico SA, TSCA, FDA , EPA, Hazard Communication and their analogues on a...processes, procedures, and tools needed to ensure ongoing product regulatory compliance and product risk management. +… more
- Biomat USA, Inc. (Kannapolis, NC)
- …team, responsible for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance , and achievement of production goals. This role ... medicines, solutions and services in more than 110 countries and regions. **Acknowledgment** : The Operations Manager is a key member of the donor center leadership… more
- Biomat USA, Inc. (Greenville, NC)
- …and services in more than 110 countries and regions. Acts as the general manager for a Plasma Collection Center and has overall responsibility for the center's ... of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations. **PRIMARY RESPONSIBILITIES** **:** +… more
- United Therapeutics (Raleigh, NC)
- …communications and/or commercial functions with a Master's Degree + Knowledge of compliance and regulatory framework + Exceptional soft skills including empathy ... communications, and/or commercial functions with a Master's Degree + Knowledge of compliance and regulatory framework + Exceptional soft skills including empathy… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... the management and maintenance of metrics on department adherence to regulatory requirements and department standards to ensure department quality and consistency.… more
- Lilly (Concord, NC)
- …effectively with a cross functional group. + Solid understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and/or OSHA. + ... now is the perfect opportunity! During the project phase, the Senior Manager , Parenteral Operations (Nights) is responsible for supporting staffing, training, and… more
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