Head of Regulatory Affairs
$150,000–$180,000 year
Remote · Ambler, Pennsylvania, United States or New York City, New York, United States
Ambler, Pennsylvania, United States or New York City, New York, United StatesRemoteFull Time$150,000–$180,000 yearSenior LevelDoctorate Or Professional DegreeUnknown
Type
Full Time
Level
Senior Level
Education
Doctorate Or Professional Degree
Company size
Unknown
Job Summary
Seeking a Head of Regulatory Affairs responsible for managing regulatory activities, leading the Regulatory Affairs organization, and ensuring product approvals globally. Requires advanced degree and extensive experience in regulatory science, particularly with FDA.
Required Qualifications
- A PharmD or PhD degree in a scientific discipline
- Minimum of 8 years of pharmaceutical and drug development regulatory experience
- Practical Knowledge of US regulatory pathways (505b1 and PHS 351(a))
- Substantial experience in all aspects of regulatory affairs
- Extensive knowledge of clinical development, FDA and international global clinical trial regulations
Desired Qualifications
- Experience with gene therapy products
- Experience with European regulatory authorities
- RAC certification
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