Senior Regulatory Affairs Lead: FDA Submissions & Strategy

Parexel International; Remote; CAD 80,000 - 100,000; Full time

Job summary

A leading regulatory consulting firm is seeking a Senior Regulatory Affairs Associate in Canada. This role involves serving as the primary regulatory liaison, leading regulatory strategies, and ensuring compliance with FDA requirements. The ideal candidate will possess 3–5+ years of regulatory experience, a Bachelor's degree in natural sciences, and strong project management skills. Knowledge of Veeva Vault RIMS is advantageous. The position offers a dynamic environment and opportunities for cross-functional collaboration.

Qualifications

• 3–5+ years of local regulatory experience in a health authority‑facing role.
• Demonstrated previous life cycle management experience.
• Proven expertise managing submissions and cross‑functional teams.

Responsibilities

• Serve as the primary regulatory liaison with health authorities.
• Lead and execute local documentation to meet national submission requirements.
• Support audits and inspections ensuring readiness.

Skills

Strong project management capabilities

Ability to influence cross‑functional teams

Comprehensive understanding of regulatory processes

Expertise in managing regulatory submissions

Education

Bachelor’s degree in natural sciences

Master’s or PhD in law or natural sciences

Tools

Veeva Vault RIMS

Job description

A leading regulatory consulting firm is seeking a Senior Regulatory Affairs Associate in Canada. This role involves serving as the primary regulatory liaison, leading regulatory strategies, and ensuring compliance with FDA requirements. The ideal candidate will possess 3–5+ years of regulatory experience, a Bachelor's degree in natural sciences, and strong project management skills. Knowledge of Veeva Vault RIMS is advantageous. The position offers a dynamic environment and opportunities for cross-functional collaboration.