Associate Director - Clinical Regulatory Scientist
Description:
We are seeking an experienced Associate Director - Clinical Regulatory Scientist to join our team in a permanent role. The ideal candidate will develop and execute the regulatory strategy for the US and Canadian market.
This is a hybrid working opportunity that offers flexibility and work-life balance.
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
The successful candidate will have excellent communication and negotiation skills, with the ability to assess and manage risk in a highly regulated environment. They will also have demonstrated deep knowledge of the drug development process, regulatory/business strategies and plans required.
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
Benefits:
Work From Home
Requirements:
* Bachelors degree in scientific or health sciences discipline