- American Packaging (Columbus, WI)
- …safe for their intended use. + Manage the process for other packaging based regulatory information to include Drug Master File, Sustainable Materials, End of ... Corporate Regulatory Compliance Manager Columbus, WI (http://maps.google.com/maps?q=Corporate+WI+Columbus+WI+USA+53925) Description At American Packaging Corporation… more
- ICON Clinical Research (NC)
- …and therapies. **What you will be doing:** + Participate in provision of regulatory expertise in strategic drug development across multiple areas. + Take ... Senior Manager, Regulatory Affairs - IVD ICON plc is a...to shape the future of clinical development. Sr Manager, Regulatory Affairs - IVD Location: US Remote, Portland, OR… more
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …exceptional leadership capabilities, and the ability to contribute meaningfully to drug development and regulatory strategies while fostering collaboration and ... efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints, and frame… more
- Bristol Myers Squibb (San Diego, CA)
- …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
- 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
- Astellas Pharma (Northbrook, IL)
- …(RWE) analytics, and statistical programming. + Strong understanding of the drug development lifecycle, regulatory requirements, and evidence generation for ... optimization, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning… 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
- Merck (North Wales, PA)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... a clinical trial environment. **Requirements:** + Experience in US and/or worldwide drug or vaccine regulatory application submission including the development… more
- Bristol Myers Squibb (Madison, NJ)
- … Development leader; with greater than 5 years of extensive clinical trial and drug development experience and regulatory experience, in addition to a strong ... and oversight for one or more clinical trials within the Global Drug Development organization. This position will provide the candidate an opportunity to… more