GLOBAL REGULATORY AFFAIRS CMC jobs in BOSTON MA, United Kingdom

Center 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...

to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring... consultants, development partners, and global health authorities. Responsibilities Act as Regulatory CMC Lead for assigned...

at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams... organizations, expert consultants, development partners, and global health authorities. Responsibilities Act as Regulatory CMC...

are 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...

Center 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...

Job title: Global Regulatory Affairs Lead Location: Cambridge, MA or Bridgewater, NJ About the job The Global.../biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and global), in early...

Job Description General Summary: The Associate Director, Regulatory CMC executes multi-product global regulatory..., as well as the interactions and responses with regulatory agencies Develops global CMC regulatory strategies...

questions within defined timelines. Perform assessment of CMC changes, identifying global regulatory requirements...Responsibilities: Author and review high-quality, compliant CMC regulatory documents (e.g., Core Dossiers, INDs, CTAs...

with regulatory affairs to address CMC-related queries and inspections from regulatory agencies. Implement robust quality control... CMC regulatory strategies and lead the preparation of CMC sections for regulatory submissions. Collaborate...

with regulatory affairs to address CMC-related queries and inspections from regulatory agencies. Implement robust quality control... CMC regulatory strategies and lead the preparation of CMC sections for regulatory submissions. Collaborate...

of global regulatory CMC strategies for investigational and/or commercial products Works with regulatory colleagues in... development of global regulatory CMC strategies and submissions Provides regulatory CMC guidance to cross-functional teams...

opportunity to primarily work with Global and Regional Regulatory Leads who are responsible to develop the regulatory strategy... and prepare high quality global regulatory submissions for early-stage development programs. Early-stage programs encompass...

/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early... could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...

experience (regionally and global), in early and late stage development of multiple modalities; experience within regulatory CMC..., and strategic partner to the GRL, the RS leverages their regulatory expertise to contribute to the definition of the global...

to Pharmaceutical Sciences (CMC) Early-Stage Portfolio Leader and mentor and cultivate best practices in the Functional PS-Lead global... global CMC development teams dealing with complex development programs that require scientific depth and overall product...

, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.) to achieve expected outcomes. Exhibited ability to problem-solve.../pharmacovigilance, and regulatory affairs. Demonstration of exceptional collaborative skills and an ability to lead, understands the...

of regulatory submissions, and leads the interactions and responses with regulatory agencies Leads the development of global CMC... regulatory CMC strategies for investigational and marketed products. This role is accountable for the preparation and filing...