Regulatory Affairs Associate Hybrid Role

Elevate your career with a hybrid Regulatory Affairs Associate position, focusing on FDA and Health Canada submissions. Leverage your expertise in eCTD formats and regulatory compliance.

In this Associate role, you'll prepare drug product submissions for the US FDA and Health Canada while assisting with global registrations. You'll need a thorough understanding of various dosage forms including solids and injectables along with regulatory guidelines. Your contributions are vital for compliance and successful drug registration.

Key Responsibilities:
• Prepare and review eCTD submissions for regulatory agencies
• Respond to deficiency letters from agencies promptly
• Maintain approved product monographs and annual reports
• Review product labeling and internal documentation
• Assist with global drug product registrations

Requirements:
• B. Sc. in Chemistry, Pharmacy, or Life Sciences
• 3-5 years of experienc...