- Organon & Co. (Jersey City, NJ)
- …products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures ... company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies,...or EMA; prepare our company's teams for meetings with FDA or EMA at any phase of drug… more
- Ascendis Pharma (Princeton, NJ)
- …with prescription drug , biologic, and/or combination products; experience managing major regulatory filing(s) to the FDA Office of Prescription Drug ... regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs,… more
- Tecomet (Woburn, MA)
- …as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). + Assist and complete site FDA /ISO/AS/EAR Registrations + ... Host FDA and government and notified regulatory agencies audits. + Review and interpret regulatory...ACTION EMPLOYER / PROTECTED / VETERANS / DISABILITIES / DRUG FREE WORKPLACE** **TRAVEL REQUIREMENTS:** X **YES** **NO** **INTENT… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …co-promote partner companies + Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, ... The Senior Manager position within the Regulatory Affairs department requires the ability to apply...helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion… more
- Lilly (Indianapolis, IN)
- …supervision. The Sr. Director must also develop mutually productive relationships with the FDA Office of Prescription Drug Promotion (OPDP), Lilly components and ... across GRA** + Partnering with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising… more
- University of Washington (Seattle, WA)
- …prioritization of all regulatory affairs to ensure timely submissions to regulatory bodies (IRB, FDA , sponsor, etc.). * Oversee, coordinate, and implement ... serious adverse events, and protocol deviations. * Maintains and updates all required regulatory documents ( FDA Form 1572 and/or 1571, protocol signature page,… more
- IQVIA (Durham, NC)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... and consortia + Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the… more
- RWJBarnabas Health (West Orange, NJ)
- …years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting + Comprehensive knowledge ... Assistant Vice President of Legal Affairs, Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas… more
- Dana-Farber Cancer Institute (Brookline, 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, Serious… more
- Globus Medical, Inc. (Audubon, PA)
- …clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This ... position entails development of FDA submissions, requires working knowledge of products under review...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
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