- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… more
- Aldevron (New York, NY)
- …processes and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs , and Marketing, to develop labeling strategies that ... to maintain labeling integrity.Collaborate with internal stakeholders: Work closely with Regulatory Affairs , Quality Assurance, and Manufacturing teams to ensure… more
- Beckman Coulter Diagnostics (Miami, FL)
- …experience in:Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (eg CQM, CQE, CQA, RAC, ... GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB). This...Regulation (IVDR) as well as all other applicable global regulatory requirements.Maintain oversight, tracking, metric reporting and escalation of… more
- Aldevron (Miami, FL)
- …that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be ... a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation and will be responsible for representing the Analytical… more
- Aldevron (Miami, FL)
- …that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be ... a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation. You will assist in representing the Analytical Method… more
- Teva Pharmaceuticals (West Chester, PA)
- …make a difference with. **How you'll spend your day** Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester, PA office to: + ... Manager , Regulatory Affairs Date:... Manager , Regulatory Affairs Date: May 5, 2025...2 years of experience in the biotech/pharmaceutical industry in Regulatory Affairs ( RA ) or a… more
- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager ** position is an onsite ... Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is...discipline. + Advanced degree or additional professional training in regulatory affairs ( RA ) desired. +… more
- Abbott (Santa Clara, CA)
- …in Santa Clara, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within ... member is responsible for the management and leadership of Regulatory Affairs activities for an early stage...Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and… more
