opportunity. The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP... with company strategies and Health Authority requirements. The Manager/Senior Manager will also participate to formulate regulatory...
AlkermesCMC/CP regulatory issues and develop appropriate strategies to mitigate or fix them, independently finds alternative... Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC/CP prduct...
Regeneron Pharmaceuticals+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience... preferred. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions...
Katalyst Healthcares & Life SciencesProvide CMC regulatory expertise for investigational and marketed products to project teams. Establish CMC regulatory... and guidelines. Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities...
OtsukaJob Description About This Role This role is responsible for Regulatory CMC expertise into the development... and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products...
BiogenJob Description About This Role This role is responsible for Regulatory CMC expertise into the development... and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products...
Biogenmanagement system. ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director... requirements. Knowledge/experience with CMC regulatory requirements....
TK-CHAIN LLCSenior Manager, Regulatory Affairs CMC Summary: The Senior Manager, Regulatory Affairs CMC will provide support..., and review of CMC-related regulatory documentation to ensure its suitability for submission to health authorities...
Arcus Biosciencesall therapeutic areas and product formulations. We are currently looking for a Senior Manager, Regulatory CMC to be based in the... contributing to the development and implementation of client’s regulatory CMC strategy Support client’s regulatory agency meetings...
PharmaLexof CMC filings for regulatory submissions, including IND/IMPD, BLA, and/or MAA, is highly desirable. Senior Quality Manager... professional as Manager/Senior Manager for CMC Quality Control department, with the passion and creativity to support development...
Innova Solutionsand assist in Regulatory filings (ICH/Compendial/FDA and EMA). Responsibilities: Main Focus: The CMC QC Manager/Senior...Our client is seeking a highly motivated and experienced professional as Manager/Senior Manager for CMC Quality Control...
The Steely Groupon , , , and . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops...
AbbVieon , , , and . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops...
AbbVieabout. Job Summary The Senior CMC Project Manager leads project execution after deal closure. Responsible for directing, leading... all projects at any stage through mapping resource across projects. In this role, the Senior CMC Project Manager is the key...
Charles River LaboratoriesInnova Solutions is immediately hiring a Senior CMC Project Manager Job Title: Senior CMC Project Manager Position... As a Senior CMC Project Manager, you will: The Technical PM will work with stakeholders to identify project scope and strategy...
Innova SolutionsJob Title: Senior CMC Project Manager Job Location: Seattle, WA/Warren, NJ Job Duration: 12 Months Position... development, analytical development, quality, and regulatory, to support project objectives. Develop and maintain detailed CMC...
HonorVet TechnologiesJob Title: Senior CMC Project Manager Job Location: Seattle, WA Job Duration: 12 Months Position: Technical Project... development, analytical development, quality, and regulatory, to support project objectives. Develop and maintain detailed CMC...
HonorVet Technologies