- AbbVie (North Chicago, IL)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. ... of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. + In rare… more
- Astellas Pharma (Northbrook, IL)
- …statistical science internally and externally, develop a reliable network of academics, regulatory experts, and industry peers, and lead the research area as an ... areas with a good understanding of medical literature, clinical trial, regulatory , and commercial landscape. + Have expertise in statistical methodology in… more
- Lilly (Indianapolis, IN)
- …standards. + Ensure validated processes and critical parameters align with regulatory submissions throughout the product lifecycle. + Maintain compliance with cGMPs, ... regulatory commitments, and Lilly Functional Standards; ensure inspection readiness....external technical/quality networks. + Strong understanding of cGMPs and drug product manufacturing. + Excellent communication skills, with attention… more
- Astellas Pharma (Northbrook, IL)
- …information and knowledge management, partnership and collaboration required in drug development. **Essential Job Responsibilities:** + Collaborates effectively with ... Clinical Pharmacology, Biomarker, medical safety, Toxicology (early phase programs) regulatory , biostatistics, medical affairs, Health Economics, commercial perspectives into… more
- Wells Fargo (West Des Moines, IA)
- …operations functions focused on enhancing our operational excellence, meeting our regulatory remediation efforts, and better serving customers. **The Role** Global ... compliance teams to align access processes with internal policies and regulatory requirements. + Partner with businesses, HR, Technology, and Information Security… more
- Charles River Laboratories (Rockville, MD)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... position interacts regularly with key clients as well as interfaces with regulatory agencies during inspections. This position is responsible for overseeing all… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …for Surgery. This position is responsible for managing, assessing, and executing on regulatory activities for existing drug and medical device products to create ... products through the FDA clearance/approval process, as well as other global regulatory agencies. **Responsibilities include:** + Write drug and medical device… more
- Cambrex High Point (High Point, NC)
- …a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire ... career where You Matter by applying today! Job Overview The Senior Scientist, Regulatory Compliance will provide oversight of regulatory compliance activities to… more
- University of Maryland, Baltimore (Baltimore, MD)
- …regulatory agency site visits. This program covers all major areas of drug product and biologics regulatory science, including: Chemistry, Manufacturing, and ... fulfill the faculty position of Instructor (non-tenure track) for the MS in Regulatory Science within the Department of Pharmaceutical Sciences. The MS in … more
- Truist (Charlotte, NC)
- …Financial Corporation and its subsidiaries to ensure compliance with GAAP, regulatory reporting and affiliate transaction requirements. Such complex issues include ... or external reporting requirements, which includes development of accounting, regulatory reporting and affiliate transaction policies and standards, design of… more