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Senior Regulatory Affairs Lead: FDA Submissions & Strategy
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
Education
Tools
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.