Job Summary The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional... functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality...
-related questions from FDA, EMA, PMDA, and other global health authorities. Strategy Implementation: Execute CMC regulatory...+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related...
challenge the status quo for the better. Who we are looking for Purpose Currently seeking a Regulatory Affairs (RA) Senior... Manager with strong CMC pre and post approval experience to support Chiesi's Global Rare Diseases (GRD) global portfolio...
Responsibilities: The Senior Manager, Regulatory CMC Technical Writing and Submission Management role... will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory filings. This role...
Responsibilities: The Senior Manager, Regulatory CMC Technical Writing and Submission Management role... will be responsible for supporting the authoring, compiling and management of CMC sections for global regulatory filings. This role...
and managing regulatory team in the generic pharmaceutical industry. Strong background in CMC aspects of drug product registration... and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet...
Job Description Summary The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices... Affairs, they are responsible for the development of complex global regulatory strategies and preparation of regulatory...
Regulatory, Data Steward & Team Lead (Sr. Manager) Vault RIM process and system is highly dependent on accurate... collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO and labelling groups to generate and maintain data...
essence of you enriches our world. We are Givaudan. Human by nature. As the global senior expert for Chemicals Management... Regulations. You will lead the development of global policies, processes and systems to ensure regulatory chemical compliance...
their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business... on , , , , and . Job Description The ME&C Associate Director is a global program management expert responsible for managing major global programs...
regulatory standards. The Senior Program Manager will serve as the primary point of accountability for assigned programs.... Job Description Primary Function of Position We are seeking an experienced Senior Program Manager to oversee and drive cross-functional...
SUMMARY/JOB PURPOSE: The Senior Operations QA Clinical GLP Manager is accountable for assisting in the development.../CMC documents submitted to regulatory agencies, GLP documents and records, etc.) Responsible for developing, tracking...
Operations regional or global study lead (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors... on X (formerly Twitter) and LinkedIn. About the role: The Clinical Trial Manager (CTM) is responsible for the...
Regulatory Affairs and Pharmaceutical development with emphasis on CMC. Experience with bio-pharmaceuticals.... We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network...
Operations regional or global study lead (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors... on X (formerly Twitter) and LinkedIn. About the role: The Clinical Trial Manager (CTM) is responsible for the...
stakeholders will vary from USA GI Region, USA CMC, Corporate Affairs or regulatory agencies. In partnership with RA project team... is to partner with the USA Regulatory Affairs team in executing key strategic and operational initiatives to achieve USA priorities...
their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business... on , , , , and . Job Description The ME&C Associate Director is a global program management expert responsible for managing major global programs...
compliant deliverables Advanced, broad understanding of global/regional/national country requirements/regulatory affairs... procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory...
their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business... on , , , , and . Job Description The ME&C Associate Director is a global program management expert responsible for managing major global programs...