GLOBAL REGULATORY AFFAIRS CMC jobs in UNITED STATES, United Kingdom #5

within CMC will facilitate product development and global registration by developing and executing regulatory strategies... and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Title...

and global registration by developing and executing regulatory strategies and effective regulatory agency interactions... lab but manufacturing and process development. This manager position within CMC will facilitate product development...

within CMC will facilitate product development and global registration by developing and executing regulatory strategies... and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle...

regulatory strategies, submissions, and plans. This position will support: Global regulatory CMC activities relevant to the... successful execution and implementation of biosimilar CMC regulatory strategies and plans throughout the product lifecycle. Development...

conditions. Summary: The candidate will be directly responsible and accountable for global regulatory product ownership... consistent with global regulatory guidance Ensure global regulatory strategy and deliverables are aligned with project teams...

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...

is responsible for overseeing the technical writers for CMC sections of global dossiers and working with CMC Regulatory Affairs... and regulatory affairs. Communicates timelines and decisions effectively throughout the company. Ensure multi-disciplinary...

(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical..., product divestment and product withdrawal. Lead development and execution of global product and project regulatory strategy...

). This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company's clinical... programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities. · Ensure CDMO...

). This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company's clinical... programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities. · Ensure CDMO...

). This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company's clinical... programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities. · Ensure CDMO...

). This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company's clinical... programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities. · Ensure CDMO...

). This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company's clinical... programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities. · Ensure CDMO...

organizational teams, and regulatory affairs. Providing strategic input: The Director, CMC-QC Contracts management may be called... record of cGMP and CMC-QC experience. The candidate has an end-to-end CMC regulatory drug approval process knowledge...

increasing levels of expertise to TA and non-TA projects within Global Regulatory Affairs(GRA) and AZ technical functions.... - Direct Regulatory Affairs CMC experience with submissions for Cell and Gene Therapy product. - Understanding of regulations...

Innova Solutions is immediately hiring for a Regulatory Affairs Project Manager Responsibilities 1. Partner...-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies 3...