- Boehringer Ingelheim (Ridgefield, CT)
- …programs, access, Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in ... areas of pharmaceutical law, one of which must be FDA Regulatory (eg, patient support programs, market...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Astellas Pharma (Northbrook, IL)
- …early and late-stage drug programs. + Provide expert guidance on diagnostic regulatory pathways including IVDR (EU), FDA (IDE, 510(k), PMA), and other global ... record working in pharma of successful submissions under IVDR and FDA diagnostic regulatory pathways for drug clinical studies and companion diagnostics.… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, drug safety, market research, ... This position with the Regeneron Regulatory and Commercial Law team will provide proactive...to multiple internal stakeholders, including the commercial, medical affairs, regulatory , HEOR, corporate affairs, and compliance teams. Counsel will… more
- AbbVie (Washington, DC)
- …The Director, US Policy will monitor, track, and analyze key US Food and Drug Administration ( FDA ) public policy issues that could impact AbbVie and the ... Policy & Analytics (USPA) team for all legislative and regulatory policy developments related to FDA . The...legislative and regulatory policy developments related to FDA . The Director will work with internal stakeholders to… more
- WuXi AppTec (Middletown, DE)
- … Compliance * Ensure all analytical testing meets FDA , EMA, and ICH regulatory requirements for drug product QC. * Maintain compliance with data integrity ... Strong understanding of ICH, USP, EP, JP, FDA , and EMA regulatory requirements for drug product QC. * Demonstrated ability to manage teams in a fast-paced… more
- WuXi AppTec (Middletown, DE)
- … Compliance * Ensure all analytical testing meets FDA , EMA, and ICH regulatory requirements for drug product QC. * Maintain compliance with data integrity ... USP <61>, <62>, <85>, <1116>, EP, JP, FDA , and EMA regulatory requirements for drug product QC. * Demonstrated ability to manage teams in a fast-paced… more
- Boehringer Ingelheim (Ridgefield, CT)
- …teams throughout the product lifecycle. This role will provide US strategic regulatory guidance to facilitate efficient and compliant drug development and ... with a minimum of ten (10) years' experience in Regulatory Affairs, FDA , or equivalent experience in...Expertise in multiple therapeutic areas and broad range of regulatory and drug development topics. + Applies… more
- University of Pennsylvania (Philadelphia, PA)
- …Regulatory Affairs Specialist C will, independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. ... and contribute to the development/maintenance of study-specific case report forms for FDA reporting, as well as provide direct regulatory /compliance guidance.… more
- Boehringer Ingelheim (Ridgefield, CT)
- …clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External ... regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RA...regulatory trends and developments for their impact on drug development activities and on existing development strategies. +… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …on assigned INDs to ensure regulatory compliance with all Food and Drug Administration ( FDA ), National Institutes of Health Office of Special Projects (NIH ... for the Clinical Trials Office to complete and oversee FDA regulatory requirements specific to vaccine research...appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities… more