- 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
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …guidance for changes to an approved (A)NDA + Write domestic device and drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes ... or more program(s), including participation in external Food and Drug Administration ( FDA ) meetings, internal core team...proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA … more
- ITG Brands (NC)
- …the development and submission of Premarket Tobacco Product Applications (PMTAs) and other regulatory filings to the FDA Center for Tobacco Products (CTP). The ... hold a PhD in a relevant scientific discipline and possess deep expertise in regulatory strategy, toxicology, clinical studies, and FDA engagement. - WHAT YOU… more
- Ascendis Pharma (Princeton, NJ)
- …combination products. + Experience managing major regulatory filing(s) to the FDA Office of Prescription Drug Promotion (eg, launch advisory comment ... regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs,… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an… more
- Houston Methodist (Houston, TX)
- …developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the ... International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of… more
- Sumitomo Pharma (Little Rock, AR)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more
- Globus Medical, Inc. (Audubon, PA)
- …and gaining approval of 510(k), IDE, and PMA submissions to the US Food and Drug Administration ( FDA ) for class II and class III products. This position entails ... Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to… more
- Stanford Health Care (Palo Alto, CA)
- …Clinic Administration, Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug ... federal and state levels. + Knowledge of other relevant regulatory guidelines (eg, CMS, 340B, FDA ). +...other relevant regulatory guidelines (eg, CMS, 340B, FDA ). + Knowledge of theories, principles, practices and techniques… more
- Houston Methodist (Houston, TX)
- …developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the ... International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of… more
- Dana-Farber Cancer Institute (Boston, MA)
- …reports, to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, ... documents for SRC and IRB review and approval. + Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports,… more