Regulatory Affairs Consultant

Job Summary

A company is looking for a Consultant to join their Regulatory Affairs team.

Key Responsibilities

• Provide ad-hoc regulatory guidance across critical therapeutic areas
• Navigate complex regulatory landscapes for specified therapeutic areas
• Consult in domain areas to enhance service offerings and contribute to clinical trials

Required Qualifications

• Minimum BS degree in a science-related field plus 3+ years as a Regulatory Project Manager or equivalent
• Prior experience working directly for the FDA required
• Demonstrated expertise in Neuroscience, Pediatrics, Rare Disease, or Women's Health
• Advanced knowledge of US and International regulatory requirements
• Ability to work independently on a flexible, project-by-project basis