SENIOR MANAGER REGULATORY CMC jobs in CAMBRIDGE MA, United Kingdom

Job 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...

Job 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...

all 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...

Job Description The Senior Director, CMC Product Leader for Biopharmaceutical Sciences-Cell & Gene Therapy, will lead... CMC regulatory strategies and lead the preparation of CMC sections for regulatory submissions. Collaborate...

Job Description The Senior Director, CMC Product Leader for Biopharmaceutical Sciences-Cell & Gene Therapy, will lead... CMC regulatory strategies and lead the preparation of CMC sections for regulatory submissions. Collaborate...

Job Description GENERAL POSITION SUMMARY: The Senior Manager, Quality Validation and Engineering is responsible... CMC regulatory considerations Experience with equipment, facilities and utility system qualifications activities in...

We are looking to hire a Senior Manager/Associate Director of Clinical Pharmacology to join us in our mission... including DMPK, translational medicine, clinical development, clinical operations, regulatory, CMC, and project management...

Job Description General Summary: The Senior Manager, Quality Analytical Microbiology is an advanced technical... resource in the principles and application of microbiology quality assurance and compliance. The Senior Manager, Quality...

in Boston, MA. Formulation Development group is a fast paced and high energy environment. The Senior Director in... corresponding regulatory submissions Utilize and support the use of a mixture of computational models, small scale characterization...

of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Scientist – Analytical... to drive efficient progress to early regulatory agency filings. You will also leverage analytical technical skill...

across sites. Support OOS investigations, preparation of specifications, CMC clinical and commercial regulatory submissions. Work...Job Description The Senior Director of Product Quality is accountable for end-to-end quality oversight of cell...

, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.) to achieve expected outcomes. Exhibited ability to problem-solve...Our client is looking to add a Study Manager to their team on a permanent basis. Based in Cambridge, MA, this role...

Reporting to the Director, Clinical Operations, the Senior Study Manager, Clinical Operations is responsible... a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency. Supports...

knowledge of the following in a pharmaceutical setting: CGMP’s and associated CMC regulatory considerations experience... alignment with corporate goals and compliance with all regulatory requirements. In addition, the leader will also oversee QC...