- Lilly (Concord, NC)
- …+ Interact with peers across the parenteral network, including TS/MS, QA, QC, Regulatory and Engineering, both site and central + Share learning and ensure ... strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations. + play a critical role in technical capability… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …Validation, DP Process Development, Process Analytical Sciences, Combination Products, Regulatory , Quality Assurance and Quality Control. + Leads tech transfer ... use on manufacturing equipment. + Reviews Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed. + Supports SOP… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …processes are properly logged, monitored, and aligned to enterprise standards. Policy & Regulatory Monitoring + Track and manage internal and external policy and ... regulatory changes that may impact communications, brand reputation, or...documentation + Budget management + Executive communication and data story telling Domestic Travel - 10% International Travel -… more
- Lilly (Boston, MA)
- …to novel genetic medicine therapeutic modalities + Understanding of pharmaceutical regulatory guidance and expectations + Agile interrogation of diverse data (eg, ... interdisciplinary teams + Lead the preparation of ADME portions of regulatory communications and documents to support clinical development, new drug applications,… more
- New York State Civil Service (New York, NY)
- …and adopted regulations;* Provides legal advice on matters regarding regulatory actions and developing legal approaches to accomplish various departmental ... related corporate actions; commercial financial documentation and negotiation; bank regulatory experience; insurance regulatory and legislative experience; and… more
- Reckitt (Wilson, NC)
- …process improvements with engineering, maintenance, and production teams. + Maintain regulatory alignment (GMP, FDA, ISO, EHS) and current schematics. + Execute ... operational excellence. **_This role is not currently sponsoring visas or considering international movement at this time._** **The experience we're looking for** +… more
- 3M (Cottage Grove, MN)
- …within the site. + Interpreting, implementing, coordinating, and maintaining the regulatory compliance rhythm to assure completion of reporting and recording for ... the businesses of the division/staff organization. + Evaluating complex regulatory challenges across environmental medias related to dynamic manufacturing… more
- CDM Smith (El Paso, TX)
- …or special case designs, studies, etc. -Maintains client, industry, and regulatory agency contacts; participates in relevant professional organizations; attends and ... contact. -Supports project delivery team through interpretation of technical and regulatory issues, assisting with project scoping and budgeting, and achieving… more
- IQVIA (Durham, NC)
- …and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Work with sites to adapt, drive, ... issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF)… more
- Rochester Regional Health (Rochester, NY)
- …comprehensive unit-based safety programs (CUSP) in alignment with national and international standards. + Collaborate with cross-functional teams to address risks ... policies and procedures related to patient safety, ensuring compliance with regulatory requirements. + Work collaboratively with relevant departments to ensure… more