be for you! As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC... and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission...
GlaxoSmithKlineSenior Manager, Regulatory Affairs CMC Summary: The Senior Manager, Regulatory Affairs CMC will provide support... on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual...
Arcus Biosciencesrole. Regulatory Affairs Manager, CMC. Live What you will do Let’s do this. Let’s change the world. In this vital.... The Regulatory Affairs professional we seek is a leader with these qualifications. Facilitate product development...
AmgenCenter Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements...: Master’s degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include...
Takedaimprove the world. And that’s the kind of work we want to be part of. The Regulatory Affairs CMC Manager II will support the... site and customer related regulatory affairs and CMC project activities. Work collaboratively with appropriate company...
Lonzaopportunity. The Manager/Senior Manager of CMC Regulatory Affairs will be responsible for supporting commercial CMC and GMP... of CMC information and annual reports. Represent Regulatory Affairs in various internal cross-functional project teams...
Alkermes+ 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 SciencesCMC/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 PharmaceuticalsProvide 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...
Otsukaare properly and timely implemented. Provide support to Regulatory CMC managers in developing strategy for development projects..., including assigned projects and back-up projects. Participate in CMC project team meetings and provide Regulatory CMC support...
Katalyst Healthcares & Life SciencesJob Title: CMC 2 Regulatory affairs / Animal Health Care Location: Remote Hire Type: 6+ Month Contract... field (advanced degree preferred). Proven and relevant regulatory affairs experience in pharmaceutical, vaccine...
Net2Source, Global Regulatory Affairs CMC is responsible to oversee and help develop regulatory strategies to support development... Director, Regulatory Affairs CMC is also responsible for the oversight of maintaining and updating CMC sections of submissions...
Teva Pharmaceuticalsall therapeutic areas and product formulations. We are currently looking for a Senior Manager, Regulatory CMC to be based in the... development or regulatory experience in CMC in the Pharma or Biotech industry Established experience in regulatory affairs...
PharmaLexand execution of regulatory CMC plans for assigned development and commercial projects leading to successful preparation..., but are not limited to): Responsible for the regulatory CMC strategy and execution for assigned commercial and development projects...
Neurocrine BiosciencesJob Description General Summary: The Associate Director, Regulatory CMC executes multi-product global regulatory... and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics. This role...
Vertex Pharmaceuticalsmanagement 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...
TK-CHAIN LLCCenter Americas, Inc. is seeking a Manager, Global Regulatory Affairs, Marketed Products in Cambridge, MA with the following... regulatory pathway and history (including competitive regulatory analysis) by researching pre-clinical, clinical, CMC and post...
Takeda