- Georgetown Univerisity (Washington, DC)
- …science, or related field + Minimum of 2 years of experience in regulatory affairs or clinical research + FDA , ICH-GCP) Familiarity with regulatory ... regulatory compliance and oversight of a portfolio of clinical trials overseen by the Clinical Research...the Director of the CRO, the CRC will manage regulatory for complex clinical trials across multiple… more
- Boehringer Ingelheim (Ridgefield, CT)
- …drug development experience/knowledge with a minimum of ten (10) years' experience in Regulatory Affairs , FDA , or equivalent experience in the regulated ... drug development experience/knowledge with a minimum of eight (8) years of experience in Regulatory Affairs , FDA , or equivalent experience in the regulated… more
- Boehringer Ingelheim (Ridgefield, CT)
- … strategy expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory ... common goals for assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: + Regulatory Professionalism: + As… more
- University of Colorado (Aurora, CO)
- …- Senior/Level 3) - 36956 University Staff As an important member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position works ... ** Regulatory Affairs Coordinator (Open Rank: Entry/Level...sponsored (Pharmaceutical), Cooperative Group (NCTN) and/ or Investigator initiated clinical trials in accordance with FDA Regulations,… more
- Sumitomo Pharma (Little Rock, AR)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... individual will be responsible for leading development of all non- clinical and clinical regulatory strategies...to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory ... Under the mentorship of the Sr. RA Manager of Regulatory Affairs , they are responsible for the...to ensure that the product development process - including clinical studies and strategy - addresses all regulatory… more
- Kelly Services (Norcross, GA)
- …BLA submissions** . + Experience supporting multicenter clinical trials and FDA BIMO audits. + Strong relationships with regulatory agencies and consultants. ... a direct hire opportunity in the Norcross, GA area for a Director, Regulatory Affairs (Transfusion).** **Director, Regulatory Affairs (Transfusion)**… more
- PCI Pharma Services (Rockford, IL)
- …across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives ... matters of government and regulations, with respect to the FDA , DEA, MHRA, EEU, State of Illinois, and other...and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing… more
- Medtronic (North Haven, CT)
- …for this opening will close on - 30 Dec 2025 **Position Description:** Sr. Regulatory Affairs Specialist for Covidien, LP (a Medtronic company) located in North ... design/manufacturing change notifications, QMS audits, and Manufacturing site registrations. Provide Regulatory Affairs support for maintenance of Core Suture… more
- Kelly Services (Norcross, GA)
- …to offer a direct hire opportunity in the Norcross, GA area for a Principal, Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / ... the Role** We are seeking a highly skilled Principal, Regulatory Affairs professional to manage pre-market ...in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA , Health Canada,… more
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