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Director of Regulatory Operations

1 week ago

Cork, Cork, Ireland Life Science Recruitment Full time
Job Description:

A key role has arisen for a Regulatory Affairs Director to join our client's Global Business Centre. The successful candidate will be responsible for leading the development and maintenance of global labeling, including core labeling documents related to drug, device, CMC, and carton/container components.

The purpose of this role is to provide leadership for the development of global labeling strategies, facilitate global simultaneous submissions, and ensure timely delivery of global labeling to clients' affiliates. Additionally, the successful candidate will lead timely updates and communication of core labeling changes throughout the product lifecycle.

Key Responsibilities:
  • Provide leadership for the development of global labeling strategies.
  • Implement initiatives related to global labeling strategy.
  • Serve as a global labeling representative for assigned products.

Requirements:
  • Bachelor's degree in a scientific or health sciences discipline.
  • Minimum 2 years industry-related experience in regulatory affairs and/or drug development.
  • Demonstrated knowledge of the drug development process and regulatory/business strategies.
  • Demonstrated ability to assess and manage risk in a highly regulatory environment.
  • Demonstrated ability to lead, influence and partner cross-functionally.
  • Demonstrated strong communication skills: writing, presenting, listening.
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.
  • Demonstrated attention to detail and organizational skills.