Clinical Regulatory Lead

4 days ago


Cork, Cork, Ireland Life Science Recruitment Full time
This role presents an exciting opportunity for a highly motivated and experienced Clinical Regulatory Scientist to take on a leadership position within our client's team. As Associate Director - Clinical Regulatory Scientist, you will be responsible for developing and executing regulatory strategies for the US and Canadian markets, working closely with cross-functional teams to deliver integrated regulatory solutions.

Responsibilities:
  • Develop and update US and Canada registration strategies, leveraging scientific, drug/device clinical development, and knowledge from FDA/HC meetings and regulatory trends.
  • Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by the organization and knowledge of competitor labelling.
  • Monitor upcoming and recent approvals of competitive development programs/plans.
  • Integrate US/CA regulatory strategy into global registration strategy.
  • Partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy.

Requirements:

Bachelor's 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.

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.

Demonstrated strong written, spoken, and presentation communication.

Demonstrated negotiation and influence skills.

Demonstrated attention to detail.

Demonstrated effective teamwork skills; able to adapt to diverse interpersonal skills.



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