on , , , , and . Job Description The Associate Director, RA CMC Post Approval Change Dossier Manager is responsible for ensuring RA-CMC post approval... preparation of CMC sections of regulatory dossiers including electronic submissions Strong working knowledge of manufacturing...
on , , , and . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... and procedures. Analyzes and approves manufacturing change requests. Represents CMC regulatory affairs on teams such as the product...
Job Title: Director/Senior Associate Director, Global Regulatory Affairs CMC Job Location: Ridgefield, CT 06877, USA... Associate Director, Global Regulatory Affairs CMC for Chemical products to join our dynamic team. As a global leader in the...
you to apply to jobs of interest and we will review applications upon our return.” Position Summary The Associate Director, CMC Regulatory Affairs... Executive Director, CMC Regulatory Affairs. Responsibilities Interpret global regulations and guidance to identify risks...
Job Description: This role is considered Hybrid. Responsibilities: The Associate Director, Regulatory Affairs CMC... is responsible for helping to derive and implement the global regulatory CMC strategy for commercial programs. The Associate Director...
dossiers. Reporting to the Director, Regulatory Affairs, the Associate Director will provide strategic oversight, ensure..., Regulatory Affairs CMC will develop and execute global regulatory CMC strategies to support drug development programs...
a dedicated and innovative Director/Senior Associate Director, Global Regulatory Affairs CMC for Chemical products... for our employees. The GRL CMC Director or Senior Associate Director has responsibility for the strategic global CMC RA management...
closely with the PSC/CMC, Regulatory Affairs, and Quality Assurance departments, as well as with cross-functional project... changes through completion. Liaise internally with other members of the Regulatory Affairs department to coordinate CMC...
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...
Job Title: Associate Director, Regulatory Affairs Job Location: United States Job Location Type: Remote..., and experienced individual for the position of Associate Director, Regulatory Affairs. The Associate Director is part of the Global...
. Could you be our next Associate Director, Global Regulatory Affairs? The job is located in our King of Prussia PA office. This is a hybrid position.... You will report to the Director of Global Regulatory Affairs. Responsibilities: You are a member of a Regional Therapeutic Area...
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...
and approval of our innovative therapies. Responsibilities: The Associate Director of regulatory Affairs will be responsible... to join our team as an Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The...
. Regulatory Affairs Director - Inflammation and Rare Disease What you will do Let’s do this. Let’s change the world. Amgen... is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease Therapeutic Area. Global...
as an Associate Director, Regulatory Project Management. The Associate Director, Regulatory Project Management will manage Cartesian...'s regulatory portfolio of US and ex-US filings, supporting both the clinical and CMC regulatory leaders. Key Responsibilities...
The Associate Director of Analytical Development Biologics will lead a team of analytical scientists responsible..., preparation and reviewing of CMC content for regulatory submissions, as well as response to regulatory agencies. This role...
of development programs Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program...Job Title: Associate Director/Director Non-Clinical Safety (Toxicology) Job Location: United States Job Location...
with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams...SUMMARY/JOB PURPOSE: The Associate Clinical Supplies Director designs, develops, and implements the clinical supplies...
Overview Iovance Biotherapeutics is seeking an Associate Director, Product Quality within the Quality Assurance... organization. The Associate Director of Product Quality will develop and roll-out global product quality strategies relating to the...
Overview: Summary of Position: Assist and support the Associate Director in managing Contract Development... financial tracking. Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global...