Clinical Regulatory Strategy Lead

4 days ago


Cork, Cork, Ireland Life Science Recruitment Ltd Full time

Role Summary:

This is an exciting opportunity to work as a Senior Regulatory Affairs Professional at Life Science Recruitment Ltd. We are looking for a highly motivated and experienced individual to join our team and contribute to the development and execution of regulatory strategies for the US and Canadian market.

The successful candidate will have a strong background in regulatory affairs, with experience in developing and executing regulatory strategies, leading cross-functional teams, and collaborating with stakeholders to achieve business objectives.

In this role, you will be responsible for:

  • Developing and updating regulatory strategy documents
  • Leading the development of regulatory strategies by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends
  • Integrating information from external environment, product specific regulator advice, and other public information to develop robust, innovative regulatory strategies
  • Reviewing, summarizing, and presenting information regarding regulator expectations
  • Partnering with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy
  • Communicating and sharing key information to enable seamless execution of US/Canada regulatory strategy

Responsibilities:

  • Support the development of regulatory strategy and documentation
  • Contribute to the development of regulatory strategies by providing scientific, technical, and regulatory expertise
  • Collaborate with internal stakeholders to ensure alignment on regulatory strategies and plans
  • Provide input on regulatory issues and risks associated with product development


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