- Sumitomo Pharma (Raleigh, NC)
- …collection systems and final reports in compliance with appropriate scientific/ regulatory /medical standards + Contributes to developing clinical components of ... BLA/NDAs, sNDAs, MAAs and other regulatory filing documents + Contributes to company responses to...authority meetings, scientific advisory board meetings, and national and international scientific meetings + Serve as the subject matter… more
- Lilly (Durham, NC)
- …internal and external manufacturing network, and drive compliance with regulatory requirements. This role requires in-depth technical knowledge, strong analytical ... of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices. + Evaluate and validate visual… more
- Lilly (Raleigh, NC)
- …external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and ... SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Ensure control… more
- Xylem (Charlotte, NC)
- …global customs and trade compliance strategies aligned with corporate goals, regulatory requirements, and duty optimization opportunities. + ** Regulatory ... Monitoring & Risk Assessment** Monitor global customs and trade regulatory changes (eg, Section 232, 301, USMCA, export controls, sanctions) and assess their impact… more
- ThermoFisher Scientific (Wilmington, NC)
- …file (TMF)** **Collect/review/File study documents in support of the regulatory filing** **Responsible for overseeing study financial reconciliation** **Ensure ... studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.** **Site relationship… more
- Parexel (Raleigh, NC)
- …documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, SOPs, Good Clinical Practices, and Good ... As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company's… more
- Compass Group, North America (NC)
- …health and safety, and food safety programs across both domestic and international operations. You will provide proactive risk management support to some of ... comprehensive safety and food safety programs that meet or exceed global regulatory requirements (OSHA, ISO 45001, FDA, USDA, EU directives, Codex Alimentarius) and… more
- CAI (Raleigh, NC)
- …access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). ... including ATF Form 6 applications and USMIL import documentation + Regulatory Compliance: Determine and document applicable license exemptions and exceptions (22… more
- TD Bank (Charlotte, NC)
- …or more areas of expertise + Anticipates emerging business trends and regulatory /risk issues as a basis for recommending large-scale product, technical, functional ... & Control Self-Assessment, Business Continuity Management, Outsourcing & Vendor Management, Regulatory Compliance (eg CDIC, AML, Privacy, IDA, CBA, SOX, Basel etc.)… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global ... are licensed. Manages PV compliance audits from domestic and foreign regulatory agencies. **Primary Responsibilities:** + Manage and process all adverse events… more