Global Regulatory Affairs Manager, CMC (Pharmaceuticals)
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Job Description
Global Regulatory Affairs Manager CMC working remotely for a leading pharmaceutical company. Responsible for regulatory activities and CMC strategy.
Responsibilities:
- Responsible for global CMC regulatory activities for assigned projects and adapts quickly to changing events and priorities.
- Leads the development of CMC strategy, with support from management, for CMC submission dossiers intended to support lifecycle management activities for marketed products, in accordance with applicable regulatory and scientific standards.
- Understands, interprets, and occasionally advises teams on regulations, guidelines, procedures, and policies related to drug manufacturing and control to expedite the submission, review, and approval of global CMC applications.
- Ensures that all appropriate CMC regulatory aspects required for product market authorization are in place to guarantee continuity of market supply.
- Ensures that information submitted as part of lifecycle maintenance applications meets regional requirements, enabling maximum flexibility in supply, manufacturing, and quality with minimal unexpected questions.
Requirements:
- Bachelor's degree required; Master's degree strongly preferred
- Minimum 3 years' experience
- Bilingual in English and French
- Knowledge of regulatory procedures, systems, and guidance, as well as technical regulatory lifecycle management
- Knowledge of biologics
- Experience in CMC regulatory affairs and technical lifecycle management, preferably in biologics or vaccines; proven ability to manage routine regulatory activities
- Experience drafting CMC technical variations and Module 3 components
- Project management experience
- Experience with change control processes
- Knowledge of ICH guidelines and pharmaceutical and biological dossiers
- Knowledge of Veeva Vault is an asset
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