Senior Regulatory Affairs ManagerVirtualVocations • Lowell, Massachusetts, United States
Senior Regulatory Affairs Manager
VirtualVocations • Lowell, Massachusetts, United States
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A company is looking for a Sr Manager, Regulatory Affairs.
Key Responsibilities
Prepare and submit moderately complex regulatory submissions and documents for investigational and commercial products
Ensure product packaging and associated information are updated in accordance with product licenses
Maintain up-to-date knowledge of regulatory requirements and communicate changes to project teams and senior management
Required Qualifications
Bachelor's Degree with 8 years of experience, Master's Degree with 6 years of experience, or a PhD
Knowledge of regulatory requirements, including ICH and regional requirements
Capability to develop and implement regulatory strategy
Experience in leading a small team in preparation of submissions
Ability to provide strategic regulatory advice as appropriate
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Manager Regulatory • Lowell, Massachusetts, United States
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