Associate Director Clinical Regulatory Scientist (Paediatrics)
This role is responsible for developing and executing the regulatory strategy for the US and Canadian markets.
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 the external environment, product specific regulator advice, and other public information to develop robust, innovative regulatory strategies
* Review, summarize, and present information regarding regulator expectations
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
* Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable
The successful candidate will be a highly motivated and organized individual with excellent communication and interpersonal skills. They will have the ability to work effectively in a team environment and possess strong negotiation and influence skills.