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Associate Director Regulatory Affairs

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37338
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Associate Director Regulatory Affairs - Ireland, Dublin - 12 Month Contract

Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Associate Director Regulatory Affairs to support the Dublin function. 

Essential duties and responsibilities for this role include, but are not limited to, the following:
  • Developing and implementing global regulatory strategies for assigned products.
  • Providing regulatory strategic oversight for projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
  • Providing input to submission strategy and other critical regulatory documents.May act as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
  • May provide input to internal governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
  • Actively being up to date on latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment.
  • Support regulatory intelligence and policy priorities based on internal knowledge and expertise.
  • Ensuring exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.
Desirable experience:
  • Extensive Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
  • Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgement.
  • Experience providing strategic regulatory advice for the global development of products  through all stages of development including marketed assets.
  • Successful track record in registering and overseeing regulatory strategies for assets.
  • Bachelor’s Degree, life science highly desirable
  • Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus
If this role is of interest, please apply now.
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