Clinical Regulatory Strategy Manager

5 days ago


Cork, Cork, Ireland Life Science Recruitment Ltd Full time

We are looking for a Clinical Regulatory Strategy Manager to join our team at Life Science Recruitment Ltd. As a key member of our regulatory team, you will be responsible for developing and executing the regulatory strategy for the US and Canadian market.

The Clinical Regulatory Strategy Manager will develop, update, and execute US and Canada registration strategy. This will involve assisting or leading in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends.

Key responsibilities include integrating information from the external environment, product specific regulator advice, and other public information to develop robust, innovative regulatory strategies. The Clinical Regulatory Strategy Manager will also review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by the organisation and knowledge of competitor labelling.

Additionally, the Clinical Regulatory Strategy Manager will monitor upcoming and recent approvals of competitive development programs/plans, integrate US/CA regulatory strategy into global registration strategy, and partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy.



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