- Sumitomo Pharma (Augusta, ME)
- …Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health Hazard ... Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product...Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …+ Maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic ... standard practice, compound(s) including mechanism of action and drug landscape as well as maintaining compliance in accordance with FDA, EMEA, ICH and GCP… more
- UGI Corporation (Houston, TX)
- …responsible for facility compliance with all local, state, and federal regulatory authorities having jurisdiction, and RMP/PSM requirements. Key Characteristics: + ... operating cost, including inventory losses. + Maintain compliance with all regulatory agencies requirements that have jurisdiction with particular emphasis on… more
- Parker Hannifin Corporation (Manhattan, KS)
- …functional areas as well as with customers, field sales, regulatory agencies, division/group/corporate management, and suppliers. Essential Functions - Communicates ... customer, regulatory and organizational requirements to assure product quality, contract compliance and customer satisfaction. - Oversees the effective documentation… more
- Astellas Pharma (South San Francisco, CA)
- …a lead in developing, qualifying and transferring assays for the GMP release of drug substances and drug products as well as in-depth product characterization ... and transfer reports and SOPs. + Keep current with all regulatory guidelines, compendia requirements, work related publications and technical innovations. +… more
- Teledyne (El Segundo, CA)
- …approved FAA Certificated Repair Station facility, in accordance with CFR 145 regulatory requirements. **_This is an FAA Safety Sensitive position which requires new ... hires under this program to pass a pre-employment FAA Drug screening. Employees under this program will also be subject to random FAA Drug and Alcohol testing… more
- AUI Partners (TX)
- …including AUI employees, Subcontractors, Vendors, Owners, Architects, Engineers, and regulatory entities. Always represents AUI with the highest standard of ... direction. Stay updated with industry trends, technological advancements, and regulatory changes related to solar energy quality standards. Always adheres… more
- AbbVie (North Chicago, IL)
- …Drug Product Development (DPD), Quality Assurance (QA), and CMC- Regulatory . Responsibilities: + Utilize cutting-edge mass spectrometry techniques, including ... their area of expertise, critically evaluate relevant scientific and regulatory advances, and integrate this knowledge into research and...use that expertise to support early phase development of drug substance and drug product and collaborate… more
- Lilly (Concord, NC)
- …The Molecule Steward is the subject matter expert for the Concord Site Drug Product manufacturing and will provide local technical leadership and expertise for ... + Interact with peers across the parenteral network, including TS/MS, QA, QC, Regulatory and Engineering, both site and central + Share learning and ensure… 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