Associate Director - Clinical Regulatory Scientist
About the Role:
The successful candidate will develop and execute the regulatory strategy for the US and Canadian market, utilising their knowledge of FDA and Health Canada procedures and practices to drive business objectives.
Key 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
- Integrate information from external environment, product specific regulator advice, and other public information to develop robust, innovative regulatory strategies
Working Relationships:
- Collaborate with internal teams for the success of pricing and access strategies
- Partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy
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 drug development process, regulatory/business strategies and plans required
What We Offer:
- Hybrid working arrangement