Job Description The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets..., and cross-functional stakeholders in Regulatory Affairs. The Global Regulatory CMC Lead also supports Global Manufacturing...
Job Description The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets..., and cross-functional stakeholders in Regulatory Affairs. The Global Regulatory CMC Lead also supports Global Manufacturing...
/MAAs Lead and coordinate internal review processes to ensure timely delivery of CMC regulatory documentation Participate... and inspections/audits related to CMC regulatory aspects Monitor evolving global CMC regulatory requirements for biologics, including...
and prepare for submission CMC sections of regulatory dossiers, including for briefing packages, INDs, IMPDs, BLAs/MAAs Lead.../audits related to CMC regulatory aspects Monitor evolving global CMC regulatory requirements for biologics, including...
in writing and reviewing regulatory CMC source and submission documents, with a demonstrated ability to assess program... opportunity: The position requires deep scientific expertise and strategic vision to support the drug development portfolio (CMC...
with CMC, Development Regulatory Affairs, QPs, CMOs, and regulatory partners Lead cross-functional discussions and manage... years' experience in Technical/CMC Regulatory Affairs Strong knowledge of ICH guidelines, GMP, and global regulatory...
throughout the due diligence and negotiation process Lead and influence global cross-functional teams: skillfully navigate.... That’s what makes us Roche. The Global Pharma Strategy (GPS) team plays a pivotal role in shaping the future of healthcare by driving...
and solid-state attributes required for optimal drug product quality and manufacturing. We are seeking a seasoned leader to lead... and collective leadership. The Opportunity: Lead and develop a high performing team: Directly lead and manage the "Particle...
Manufacturing Science and Technology (MSAT) team within the Global CMC, Science & Technology Department (GCSAT), contributing... about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly...
Manufacturing Science and Technology (MSAT) team within the Global CMC, Science & Technology Department (GCSAT), contributing... about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly...
Molecules team within the Global CMC, Science & Technology Department (GCSAT), where your expertise will help shape, optimize... about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly...
Molecules team within the Global CMC, Science & Technology Department (GCSAT), where your expertise will help shape, optimize... about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly...