Regulatory Affairs Manager
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Job Summary
To support a growing clinical research organization, the full-time Global Regulatory Affairs Manager will oversee regulatory submissions, provide strategic input on regulatory requirements, and manage project timelines while working remotely within the US.
Key responsibilities
- Oversee the completeness of regulatory project deliverables and conduct expert reviews prior to client release
- Act as the point of contact for US regulatory submissions and coordinate with global stakeholders on marketing applications
- Provide strategic guidance on regulatory requirements and monitor the impact of changing regulations on submission strategies
Required qualifications
- Minimum of 5 years' experience in Regulatory Strategy or a similar field
- Expert knowledge of scientific principles and concepts related to clinical trials and pharmaceutical development
- Proficiency with MS Office applications and familiarity with eCTD submission processes
- Understanding of 21 CFR Part 11, FDA, GCP requirements, and current ISO standards preferred
- Reputation as an emerging leader in the field with a track record of sustained performance and accomplishment
Complete Job Description
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