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Contact Info
Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Head of Regulatory Affairs - Remote Work


Reference:SMC0786 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs

We're currently recruiting for an exciting opportunity with a multinational pharmaceutical organization.

Duties

  • As a senior departmental member, actively contribute to the routine operational use of Quality System
  • Plan and execute regulatory strategies for new products
  • Support the regulatory compliance of the company with the conditions of its product licences and manufacturing licences.
  • Recruit, manage and develop staff of the calibre required to meet the present and future needs of the company.
  • Provide an information and advisory service on regulatory affairs to ensure all relevant personnel within the company are briefed on current and future regulatory legislation and requirements.
  • Represent the Regulatory Affairs Department at Senior Leadership Team meetings.
  • Main activities are planning; management of staff and their work; some participation in that work; deciding on regulatory strategy and advice to management on regulatory matters.
  • Represent the Regulatory Department at internal and external meetings.
Education & Experience
  • Educated to at least honours degree level in a life science with at least ten years’ experience in regulatory affairs in an international role.
  • Membership of The Organisation for Professionals in Regulatory Affairs (TOPRA) is essential.
  • Have an appreciation of all aspects of the working of the pharmaceutical industry.