- ITG Brands (NC)
- …by complying with federal and state regulations + Ensure projects adherence to regulatory compliances, including Group & FDA . + Awareness of evolving legislation ... Manufacturing process analysis (eg, capacity, OEE calculations). + Productdesign/implementation. + Regulatory submissions. + GMP + Deep understanding of the pFMEA… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Knowledge and Skills: + Strong understanding of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as ... triaged, investigated, and resolved according to established deadlines, company and regulatory requirements. + Coordinates with cross-functional teams for testing of… more
- Actalent (Wilmington, NC)
- …work collaboratively across departments. + Familiarity with quality management systems (QMS) or regulatory standards (eg, ISO, FDA , HIPAA) is a plus. Work ... Environment This role involves cross-functional work with multiple engineering teams spanning the product lifecycle. Pay and Benefits The pay range for this position is $40.00 - $50.00/hr. Eligibility requirements apply to some benefits and may depend on your… more
- ALBEMARLE (Charlotte, NC)
- …applicable product regulatory programs, such as: Canada, Mexico SA, TSCA, FDA , EPA, Hazard Communication and their analogues on a country-by-country basis for ... and technical leadership of an America based team of Product Stewards, Regulatory , Hazard Communication and Toxicology staff. This leader will ensure regulatory… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …the accuracy and reliability of cGMP data and data supporting regulatory submissions. Generally, this requires implementing, as appropriate, and overseeing systems ... DI Network and will implement DI practices and procedures to meet regulatory requirements. Coordinate routine DI Surveillance, weekly DI awareness topics, and… more
- Merck (Durham, NC)
- …+ Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies that may include US FDA , EMEA, TGA, HPB, ANVISA, ... of international GMPs and Quality Management requirements of various regulatory agencies such as US FDA , EMEA, TGA, ANVISA, and PMDA. + Knowledge of USP… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... expansion projects. As a key technical leader, you will lead regulatory excellence while implementing forward-thinking environmental and sustainability practices and… more
- Stryker (Durham, NC)
- …you will be performing a dual-function role responsible for **ensuring regulatory compliance, workplace safety, and engineering support** within a regulated medical ... Health & Safety role responsibilities:** + Ensure compliance with OSHA, EPA, FDA , ISO 13485, and company-specific EHS standards. + Develop, implement, and maintain… more
- Biomat USA, Inc. (Kannapolis, NC)
- …responsible for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance, and achievement of production goals. This role provides ... all center activities align with company standards, SOPs, and applicable regulatory requirements. **Summary** : Assists with operational management of a Plasma… more
- CSL Plasma (Raleigh, NC)
- …of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate ... of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate… more