Director of Clinical Regulatory Affairs

7 days ago


Cork, Cork, Ireland Life Science Recruitment Ltd Full time

About the Role:

We are seeking a skilled Director of Clinical Regulatory Affairs to lead our regulatory strategy for the US and Canadian market.

As a key member of our team, you will develop and execute the regulatory strategy for new products and indications, ensuring compliance with FDA and Health Canada regulations.

This is an excellent opportunity to join a leading life sciences company and take on a leadership role in shaping our regulatory strategy.

  • Develop and execute US and Canada registration strategies
  • Initiate and update regulatory strategy documents
  • Collaborate with cross-functional teams to deliver integrated regulatory strategies
  • Communicate regulatory risks and potential impact to development team leadership

Responsibilities:

  • Develop robust, innovative regulatory strategies
  • Review and summarize information regarding regulator expectations
  • Monitor upcoming and recent approvals of competitive development programs/plans
  • Promote seamless execution of US/Canada regulatory strategy

Requirements:

  • Bachelor's degree in a scientific or health sciences discipline
  • Minimum 5-8 years' experience in regulatory affairs and/or drug development
  • Deep knowledge of FDA and Health Canada procedures and practices
  • Demonstrated ability to assess and manage risk in a highly regulated environment

Benefits:

At Life Science Recruitment Ltd, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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