SUMMARY OF POSITION The Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines... experience, at 8+ years in Regulatory Affairs with emphasis on CMC. Must have managerial experience. Exhibits excellent...
. ORGANIZATION STRUCTURE The Manager, Regulatory Affairs reports into the Director/Associate Director Regulatory Affairs... pharmaceutical industry and a Master of Science (M.S.) in Regulatory Affairs or an equivalent advanced degree preferred 5 years in...
Regulatory Submission (IRAS) submission portals in accordance with regulatory requirements, using Submission Management tools... activities with other multidisciplinary teams. Assist with the development of assigned regulatory operations work instructions...
management system. ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director..., Regulatory Affairs and is based in Morristown, New Jersey. RESPONSIBILITIES Primary responsibilities of this role include the...
SUMMARY OF POSITION The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality... regulatory affairs. Job-Specific Competencies/Skills: Excellent verbal and written communication skills. Highly motivated...
regulatory submissions, previous roles working as a CTLM, study coordinator, research nurse, or in Med Affairs Operations, formal...Overview: The Clinical Trial Liaison Manager (CTLM) is a Hybrid office-based position with regular travel in the...
business units, including but not limited to Regulatory Affairs, Medical Affairs, Legal, and Pharmacovigilance in the... for us all, both professionally and personally. Major Accountabilities: As the Manager, REMS Center of Excellence, you will work collaboratively...
strong working relationship with regions and cross functional teams including Labeling & Packaging, Medical Affairs, R&D, Regulatory... location is seeking a Global Product Manager for the Core Assays Portfolio. This role encompasses global leadership...
. The focus of this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs... particular security architects and Genmab Security Operations Team Business leaders (e.g., VP Medical Affairs, VP Regulatory...