Job details
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Manager, Regulatory Affairs
Apogee Therapeutics is a biotechnology company focused on developing differentiated biologics for inflammatory and immunology indications. They are seeking a Manager of Regulatory Affairs to oversee regulatory strategies for product submissions.
Skills
- Regulatory experience
- Project management
- Strong communication skills
- Experience with Veeva RIM
- Knowledge of FDA and EMA regulations
Responsibilities
- Interact with project and clinical study teams for regulatory submissions
- Support data collection and author regulatory documents
- Communicate submission timelines and follow up
- Serve as primary interface for electronic submissions
- Maintain regulatory submissions and correspondences
- Implement templates and guidelines for documentation
- Understand and communicate regulatory requirements
- Support global regulatory leads on clinical study teams
Education
- BS/MS/PhD in regulatory affairs or related discipline
- Regulatory Affairs Certification (preferred)
Benefits
- Market competitive compensation
- Performance bonus
- Equity grant opportunities
- Flexible PTO
- Company-wide shutdowns
- Professional development resources
To read the complete job description, please click on the ‘Apply’ button
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FUNDING
DEPARTMENTS
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
LOCATION
SALARY RANGE
$120,000/yr - $140,000/yr
EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
November 18, 2024
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