Clinical Regulatory Manager

Job Summary

A company is looking for a Manager, Clinical Regulatory to join their team.

Key Responsibilities:

• Manage regulatory aspects of clinical studies and create high-quality regulatory submissions
• Author and review clinical modules of applications and amendments for submission
• Represent Clinical Regulatory Affairs on cross-functional project teams and provide strategic regulatory guidance

Qualifications:

• BA/BS in a scientific field and 3-5 years of relevant experience
• Knowledge of US regulatory requirements and experience in regulatory affairs
• Strong organizational skills with the ability to manage multiple timelines
• Experience in CMC development of biologics preferred
• Familiarity with regulatory information management systems, such as Veeva Vault RIM, is a plus