Regulatory Cmc Jobs in Cambridge, MA

Takeda - Cambridge, MA, United States

you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team’s success in meeting goals/objectives. You will also influence changing regulations and guidance

from: linkedin.com - 23 days ago

Leap Therapeutics - Cambridge, MA, United States

, internal stake holders (i.e., Clinical Operations, translational medicine, medical, biometrics, regulatory, CMC, etc.) and external vendors Education / Experience / Skills: PhD in pharmacokinetics, clinical

from: linkedin.com - 19 days ago

Katalyst Healthcares & Life Sciences - Cambridge, Massachusetts

appropriate requirements and standards are properly and timely implemented. Provide support to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up

from: resume-library.com - Yesterday

Stratacuity: Proven Scientific Placement - Cambridge, MA, United States

clinical manufacturing Prepare and oversee IND enabling including regulatory CMC sections Primary Job Requirements: Seasoned leader who possesses a PhD with 10 or more years in industry with strong experince

from: linkedin.com - 13 days ago

Leap Therapeutics - Cambridge, MA, United States

closely and collaboratively with Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory and program management staff as well as Clinical Research Organizations

from: linkedin.com - 13 days ago

Editas Medicine - Cambridge, Massachusetts

to support successful outcomes. The individual will work extensively with cross-functional teams in the execution of these submissions. Key Responsibilities: As the Director, Regulatory CMC

from: resume-library.com - 24 days ago

Leap Therapeutics - Cambridge, MA, United States

. Coordinate Quality Events (Deviations, Investigations, CAPAs) with CMOs and escalate them to QA management. Collaborate with CMC and RA in the implementation of product specifications at vendors

from: linkedin.com - 24 days ago

Editas Medicine - Cambridge, MA

to support successful outcomes. The individual will work extensively with cross-functional teams in the execution of these submissions. Key Responsibilities: As the Director, Regulatory CMC

from: workable.com - More than 30 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 - 24 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 - 7 days ago