Director of Regulatory Strategy
5 days ago
Role Overview
The Director of Regulatory Strategy will develop and execute the regulatory strategy for the US and Canadian market.
This role offers hybrid working and requires a strong understanding of FDA and Health Canada procedures and practices across Review Divisions.
Main Responsibilities:
- Develop, Update and Execute US and Canada Registration Strategy
- Initiate and Update Regulatory Strategy Document
- Assist or lead in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends
Key Requirements:
- Bachelors degree in scientific or health sciences discipline
- Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5-8 years
- Demonstrated deep knowledge of the drug development process, regulatory/business strategies and plans required
- Demonstrated ability to assess and manage risk in a highly regulated environment
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