) Proclinical is seeking a Project Coordinator to join the Regulatory Affairs - CMC Team. Primary Responsibilities: The... Posting date: 23 Jan 2025 Reference: 63940 Project Coordinator - Regulatory CMC - Contract - Cambridge, MA (hybrid role...
Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit.... This position will be responsible for auditing/reviewing regulatory submissions, working closely with the Regulatory Affairs...
of multi-product global regulatory CMC strategies for investigational and marketed products. This role is accountable for the... preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics...
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...
Job Title: Sr Manager, Regulatory Affairs Job Location: United States Job Location Type: Remote Job Contract... that you will share this mission with us. Senior Manager, Regulatory Affairs Would you like to join a team of global Regulatory...
." Who we are looking for Purpose Currently seeking for a Regulatory Affairs (RA) Manager with strong CMC pre and post... functional teams in obtaining the necessary CMC documentation in support of a regulatory submission. Assist in the development...
a Regulatory/Senior Regulatory Affairs Manager in our FSP, Regulatory Team. This role will be hired at Manager/Senior Manager...Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Manager/Sr. Manager Regulatory...
material from clinical to commercial. Based in Houston, the Regulatory Affairs Manager will support the site’s and customers...’ regulatory affairs and CMC project activities Works collaboratively with appropriate company personnel for the organization...
Responsibilities: The Senior Manager, Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC...) Combination Products will be responsible for leading, developing, and implementing global CMC regulatory strategy related...
Job Title: Sr. Regulatory Affairs Manager Job Location: Pennsville Township, NJ, USA Job Location Type: Remote... our Regulatory Affairs for the US facility and fulfill US Agent responsibilities for all foreign Siegfried sites. Additionally...
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...
in regulatory affairs. Providing leadership in CMC team by directing analytical, DP part of CMC development for multiple product... and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC...
and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet..., submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER...
regulatory team in the generic pharmaceutical industry. Strong background in CMC aspects of drug product registration, knowledge... management regarding improvement in CMC harmonization process of regulatory documentation at all manufacturing sites. Active...
Job Title: Sr. Director, Regulatory Affairs Job Location: Boulder, CO, USA Job Location Type: Remote Job Contract... Type: Full-time Job Seniority Level: Director Enveda is looking for a Sr. Director, Regulatory Affairs to join our team...
with no prescribed procedures to solve complex problems. Global Regulatory Affairs CMC strategy, with hand-on CMC authoring... regulatory CMC strategies specific to assigned Viatris’ eyecare portfolio to meet the needs within the regions. Facilitate timely...
Job Title: Project Manager – Regulatory Project Management Location: Foster City, CA 94404 100% Onsite role.../initiatives; may attend sub-team meetings. Fosters effective and productive communication among various Regulatory Affairs groups...
Job Title: Regulatory & Quality Compliance Manager (m/f/d) Job Location: Knoxville, TN, USA Job Location... Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products). Main Responsibilities: Support as regulatory expert...
Job Title: Regulatory & Quality Compliance Manager (m/f/d) Job Location: Waltham, MA, USA Job Location Type: Remote... Manager (m/f/d) - Sterile Fluids (Medicinal Products). Main Responsibilities: Support as regulatory expert development...
meetings. Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory... Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives...