) 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...
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...
Remote Pay Range - $40-$45/hr on w2 We are inviting applications for the role of Senior Manager, Regulatory affairs... and will develop a strong team environment with colleagues throughout GRS. Responsible for implementing CMC regulatory strategies...
, Regulatory Affairs, to join our pharmaceutical team. This role will involve leading and managing regulatory activities to support... Experience: Minimum: 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry...
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...
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...
, when required. Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory... and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet...
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: Regulatory Affairs Specialist Reports To: VP Quality & Regulatory Affairs Position Status: Exempt..., risk management, CMC etc. Can be trusted by REVA management as an independent regulatory expert on strategy and issue...
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: Contract Senior Manager, Global Regulatory Strategy Location: Remote Contract: 6 months The Position... regulatory affairs lead for clinical trial activities for multiple programs. Contributes to the development of fit for purpose...
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...