- Boehringer Ingelheim (Ridgefield, CT)
- …Outlook, Word, PowerPoint, and Excel. * Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy ... **Description** The Regulatory Affairs Labeling Operations Fellowship is designed to...Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US package and product labeling. The… more
- Bristol Myers Squibb (Cambridge, MA)
- …clinical development leader; with greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong ... organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution,… more
- Norstella (Harrisburg, PA)
- …and healthcare service providers, including the top 10 global pharma and CROs. From drug and device discovery and development to regulatory approval, and from ... enabling them to cut through the clutter and make sense of changing drug development, regulatory and competitive landscapes. Now, Citeline is proud to be a part… more
- Danaher Corporation (Fargo, ND)
- …previous experience in: + Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines Aldevron, ... and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron's Fargo, ND… more
- Gilead Sciences, Inc. (Foster City, CA)
- …sciences (MD, PharmD, PhD preferred). * 10+ years of experience in pharmacovigilance, drug safety, or related regulatory roles in the biopharmaceutical industry. ... in cross-functional and executive-level forums. This leader ensures global regulatory alignment, scientific excellence, and operational rigor in all safety-related… more
- ThermoFisher Scientific (Durham, NC)
- …with the US Food and Drug Administration (FDA) - Supporting New Drug Applications (NDAs) and post-market regulatory commitments - Helping our clients bring ... platforms to automate data entry and compliance tracking - Contributing to regulatory strategy meetings that shape the direction of innovative therapies in the… more
- Astrix Technology (Monmouth County, NJ)
- …SOPs, and quality standards. + Collaborate with cross-functional teams including drug safety, regulatory affairs, clinical development, and biostatistics. + ... in medical writing with a focus on pharmacovigilance or regulatory affairs. + Strong knowledge of drug ...or regulatory affairs. + Strong knowledge of drug safety regulations and pharmacovigilance systems. + Proficiency with… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …and Research (CDER). The outcomes of divisional research will be used to inform drug development and regulatory evaluation that supports the FDA's mission to ... leading to regulatory submissions for the FDA. + Experience preparing drug applications in the pharmaceutical industry. + Familiarity with FDA regulatory … more
- Lilly (Indianapolis, IN)
- …across the company to leverage learnings, resources, and capabilities. Assurance of Drug Safety Regulatory Compliance + Maintain safety systems to support ... to staff in advance of assuming job responsibilities. + Understand regulatory and business requirements and proactively adapt policies, procedures and practices… more
- Pfizer (Cambridge, MA)
- …Experience in pharmacometric analyses + Good communication skills (written, oral). + Drug development and/or regulatory experience + Publications in relevant ... ideas, and recognizes individual contribution. **ROLE SUMMARY** + Develops model informed drug development (MIDD) plans across projects and disease areas in order to… more