Regulatory Affairs Senior Specialist

Job Summary

A company is looking for a Regulatory Affairs Senior Specialist.

Key Responsibilities

• Manage the preparation and submission of US and Canadian regulatory applications
• Provide expertise and innovative solutions on regulatory strategy and processes to clients and internal teams
• Maintain knowledge of changing regulatory requirements and liaise with regulatory authorities on behalf of clients

Required Qualifications

• Bachelor's Degree with 3-5 years of experience in Regulatory Affairs or equivalent education and experience
• Experience in the pharmaceutical industry and understanding of FDA and Canadian Regulatory Affairs procedures
• Ability to prioritize and manage multiple projects
• Experience with managing and preparing various regulatory submissions, including IND/CTA and NDA/BLA
• Ability to maintain confidentiality and adapt to changing conditions