GLOBAL REGULATORY LEAD jobs in LEXINGTON MA, United Kingdom

Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the... on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently; experience with global CMC...

with Project Vice Presidents and other colleagues across global R&D. The Nonclinical Project Director will lead nonclinical project... applications, regulatory interactions, and market registration to global regulatory authorities (e.g. IB, pre-IND, IND/CTA and NDA...

and approval Lead nonclinical project teams working with siRNA molecules and be an integrated member of the overall global project... deliveries and safety documentation for clinical trial applications, regulatory interactions, and market registration to global...

all global regions. Collaborate with team members to ensure agreement of the process with organizational goals and standards... to assess the effectiveness of the processes. Identify areas for process improvement and lead optimization projects...

for all human factors and user centered design related aspects on development projects. Strive for regulatory success of projects... by making sure that the HFE work is done in compliance with IEC 62366 & regulatory body (example, FDA) expectations...

of technical leadership, motivate, and lead technical thoughtfulness Knowledge of cGMP and other regulatory requirements related... Director QC Technical Support and will be responsible to lead the QC Investigations team in support of investigations...

REMOTE ONLY PURPOSE AND SCOPE: Responsible for leading the Global strategy and design for FME’s Total Rewards... programs including Merit Process, Salary Structures, Benchmarking Strategy, Global Job Architecture, and Short-term Incentives...

Affairs Location: Lexington, MA, US About the Department Our East Coast Global Development Hub brings together the... Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability...

About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation... across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility...

, BLA/MAA and other technical documents for regulatory agency submissions Global role requiring domestic and international... position will oversee and lead technical transfer of analytical methods and qualification, to both internal and external...