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Head of Regulatory Affairs

Ref: 9222797

  • €75,000 - €80,000
  • 26 Apr 2021
  • Tipperary
  • Perm

A leading Pharmaceutical Manufacturer in Munster is seeking to appoint a Head of Regulatory Affairs. Reporting to the Managing Director and leading a team of 6, you will form a key part of the Site Leadership team. Ideally you will be based in Munster but provision is made for remote working or for being based at their operation in Dublin. This is a great opportunity to lead the Regulatory Affairs function for a diverse manufacturing site that forms part of a global Pharmaceutical and Biotechnology company.

About the Job:

  • Plan and execute regulatory strategies for new products to ensure the fastest possible introduction of those products to the market, ensure that new product development programmes are progressed with due regard to regulatory requirements and ensure that all information provided in submissions is of a high standard, complies with regulatory requirements and is presented in a professional manner.
  • 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.
  • Assess and advise on the quality of dossiers offered for sale by other companies.
  • Identify and address the training needs of the department.
  • Allocate and prioritise work within the department to ensure the company needs are met.
  • Final sign-off of artwork.
  • Monitor legislation and professional publications to maintain awareness of current regulatory practice and advise departments on regulatory requirements/strategy.
  • Preparation of annual department budget
  • About you:

  • Minimum Honours degree level in a life science discipline.
  • At least ten years’ experience in regulatory affairs in an international role.
  • Membership of The Organisation for Professionals in Regulatory Affairs (TOPRA) is essential.
  • Requires the ability to present the Company’s interests in a professional and authoritative manner and to conduct negotiations with regulatory bodies at the highest level.
  • Sees the big picture, understands key business drivers, anticipates challenges, navigates ambiguity and complexity; keeps people focused on the right goals.
  • Secures resources and builds the team, system and culture needed to meet commitments and drive results, balances short and long terms needs and goals, and effectively leads change.
  • Independent, critical thinker with strong decision-making skills.
  • Comfortable working in a busy, fast paced regulated manufacturing environment.
  • For more on the role call Nigel on 087 3618142 or send your CV for consideration.