- Boehringer Ingelheim (Duluth, GA)
- …providing new product and marketed product regulatory strategy in the Global Regulatory Affairs ( RA ) Chemistry, Manufacturing and Controls (CMC) function ... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during...new guidelines, directives, and agency initiatives. + Acts as RA Subject Matter Expert regarding legislation and guidelines. +… more
- BeOne Medicines (Emeryville, CA)
- …Manager will collaborate cross-functionally with BeOne's internal audit operations, Regulatory Affairs , Quality, Pharmacovigilance, Safety, Clinical, CMC and ... Compliance Framework, strengthening inspection readiness and proactive risk oversight across Regulatory Affairs and Regulatory Operations. + Contribute to… more
- Nuvance Health (Norwalk, CT)
- …Communicates all new or updated protocols to appropriate staff in a timely manner. 3. Regulatory affairs and safety. Criteria A: Oversee the safety issues of the ... department and is the liaison for interdepartmental and hospital-wide safety. Regulatory affairs and safety. Criteria B: Monitoring and assuring compliance of … more
- Gilead Sciences, Inc. (Foster City, CA)
- …role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help develop the TA's ... Specific Education & Experience Requirements: + 12+ years of experience in Regulatory Affairs or other relevant industry experience + Degree in a scientific… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs , Global Regulatory Lead (GRL) role is to develop ... behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in forums that share regulatory … more
- University of Pennsylvania (Philadelphia, PA)
- …Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision ... (CROs), and the FDA, as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Start-Up… more
- Johns Hopkins University (Baltimore, MD)
- …the daily pre- and post-award research administration of divisional research administration ( RA ) teams, support a culture centered on excellent customer service, and ... maintain successful relationships with DBOs, divisional RA staff, and Principal Investigators. The Director of Research...levels of interaction and coordination with the central JHU RA leader, RA Training Lead, DBOs, divisional… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/ RA ) ... The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per...tasks with other cross-functional team members and the local RA /QA representatives for countries outside of the US and… more
- J&J Family of Companies (Danvers, MA)
- …changes to ensure labeling across the portfolio remains compliant. + Collaborate with Regulatory Affairs ( RA ) to verify labeling text, graphics, layout, ... J&J and regulatory standards. You will support cross-functional teams including Regulatory Affairs , Design, Quality and Lifecycle to ensure labeling updates… more
- Abbott (Maple Grove, MN)
- …a regulatory submission. **Preferred** **Qualifications** + Familiarity with Regulatory Affairs departmental responsibilities and processes + Familiarity of ... Regulatory teams' requests working closely with the international regulatory affiliates, the medical device business unit RA...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + 5+ years'… more