Regulatory Compliance Specialist

A company is looking for a Regulatory Compliance Specialist III.

Key Responsibilities

Support regulatory compliance for marketed products and manage regulatory activities linked to change controls

Author regulatory documents to support Marketing Authorizations and site registrations

Ensure regulatory compliance by reviewing and approving site documents and supporting batch release processes

Required Qualifications

Bachelor's degree in Biological Sciences with 2+ years of Regulatory Affairs experience, or a Master's degree in Regulatory Affairs / Quality Assurance

Knowledge of CMC topics and North American, European, and International regulations / guidelines