- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** **_Objective / Purpose:_** + Member of the Nonclinical Regulatory Writing and Submissions (NRWS) leadership who drives ... deliverables across all programs and meet corporate goals by managing nonclinical regulatory writing activities. + Represent NRWS on cross-functional teams… more
- Cardinal Health (Augusta, ME)
- …clinical operations, project management, medical affairs, legal, medical writing , nonclinical , and quality teams to ensure regulatory compliance in clinical ... biotech and medical device companies get their products to market quickly. Director , Regulatory Affairs (Clinical Submissions) is responsible for ensuring… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …management, as well as writing summary reports and documents to support regulatory filings. **As an Associate Director , a typical day might include:** + ... We are seeking a highly motivated **Associate Director ** to support Pharmacokinetics (PK) and Preclinical Pharmacokinetics/Pharmacodynamics (PPK/PD) requirements for… more
- Sanofi Group (Cambridge, MA)
- …**Minimum required skills:** Knowledgeable and experienced regarding GLP and ICH policies, regulatory nonclinical testing requirements; Writing documents for ... an overview, the incumbent will be responsible for oversight of the nonclinical safety program of Research and Development drug candidates. These activities entail… more
- Organon & Co. (Boston, MA)
- …**The** **Position** **This position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will be responsible for ... are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans....Lead will serve as the medical monitor and/or study director responsible for the execution (in conjunction with the… more
- Bristol Myers Squibb (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Therapeutic Area Audit Strategy Lead will be mainly responsible ... inspections . + External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical… more
- Kelly Services (Bridgewater, NJ)
- …requirements, and Controlled Document Management System (preferably Documentum). + Engage in regulatory writing with a clear understanding of contributions from ... clinical, and medical affairs. + Provide operational and administrative regulatory writing (cover letters, FDA forms, and...in eCTD format. + Communicate directly with and support Regulatory Product Leads and/or Director on assigned… more
- UTMB Health (Galveston, TX)
- …* Working knowledge of FDA 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies; * Working knowledge of FDA 21 CFR Part 11, Electronic ... direction of, in whole or in part, the Institutional Office of Regulated Nonclinical Studies (ORNcS). **Job Duties:** Supervision + Schedule and manage QC activities… more
- UTMB Health (Galveston, TX)
- …The Regulatory Scientist II works in conjunction with the Scientific Director for the Institutional Office of Regulated Nonclinical Studies (ORNcS), study ... Select Agent Program (FSAP). **JOB SUMMARY** **Function** : The Regulatory Scientist II will be assigned as a Study... Scientist II will be assigned as a Study Director , as defined by the US FDA Good Laboratory… more