Senior Associate Regulatory Affairs
Job Summary
Supporting regional regulatory activities, the full-time Senior Associate Regulatory Affairs will assist in preparing submissions for regulatory agencies, maintain regulatory documentation, and ensure compliance with applicable regulations while working remotely.
Key Responsibilities:
- Assist the Regional Regulatory Lead in supporting regional regulatory activities and maintaining IND/MA documentation
- Review and provide input to the Global Regulatory Strategic Plan and perform regulatory research as needed
- Coordinate the collection of functional documents and prepare regulatory packages for agency communications
Required Qualifications:
- Master's degree in a relevant field, or
- Bachelor's degree with 2 years of Regulatory Affairs experience, or
- Associate's degree with 6 years of Regulatory Affairs experience, or
- High school diploma/GED with 8 years of Regulatory Affairs experience
- Preferred: Bachelor's degree in Life Sciences with 2-3 years of Regulatory Affairs experience
Complete Job Description
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