Cmc Regulatory Affairs Jobs in Cambridge, MA

Takeda - Cambridge, MA, United States

of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. How you will contribute: Leads the Early Development Pharmaceuticals GRA CMC

from: linkedin.com - 22 days ago

Leap Therapeutics - Cambridge, MA, United States

areas – including, but not limited to - clinical operations, medical, regulatory affairs, biometrics, safety, quality, and supply – to facilitate transparent communication and knowledge sharing. Serves

from: linkedin.com - 23 days ago

GSK - Cambridge, MA

Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment

from: Pharmadiversityjobboard.com - 23 days ago

Editas Medicine - Cambridge, Massachusetts

, you will be responsible for: Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are informed

from: resume-library.com - 23 days ago

Editas Medicine - Cambridge, MA

, you will be responsible for: Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are informed

from: workable.com - More than 30 days ago

Takeda - Boston, MA, United States

Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development. You will represent the vaccine regulatory affairs team

from: linkedin.com - 6 days ago

HireMinds - Watertown, MA, United States

and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs. Formal descriptions can be supplied for interested

from: linkedin.com - 9 days ago

GSK - Waltham, MA

together. The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK

from: Pharmadiversityjobboard.com - 23 days ago

HireMinds - Boston, MA, United States

in collaboration with the CDMO teams. Partner with Quality in development of documentation required to support validation and cGMP manufacturing for sterile products. Collaborate with Regulatory Affairs partners

from: linkedin.com - 15 days ago

Mantell Associates - Boston, MA, United States

approvals Lead interactions with regulatory agencies for assigned programs Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities

from: linkedin.com - 23 days ago