- Sanofi Group (Framingham, MA)
- …and roll-out of the Sanofi Quality Management System in line with US FDA cGMP regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi ... **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job...secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity,… more
- Stanford Health Care (Palo Alto, CA)
- …front-line staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug ... Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs,… more
- CVS Health (Henderson, KY)
- …to address them + Communicate and educate staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, ... and compliance developments (eg, state Board of Pharmacy, DEA, FDA , etc.) for pending regulatory changes and...physician to receive hard copy of prescription and perform drug recall surveillance and reporting In this role, you… more
- BeOne Medicines (San Mateo, CA)
- …negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to...in the oncology therapeutic area. + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… more
- Takeda Pharmaceuticals (Boston, MA)
- …enforcement letters) or competitor complaints. + Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and ... regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory strategic oversight for… 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …to the US FDA and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health ... to function as the lead interface with the US FDA and support regional and local regulatory ...Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory… 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
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