Senior Director Regulatory Affairs

This leading U.S pharmaceutical organisation with corporate headquarters in Ireland is focused on the treatment of obesity and obesity related medical problems. This organisation’s first medicine was approved in the United States in September 2014 and has become the most prescribed branded obesity medication since June 2015. In Europe, the drug has been approved under a separate brand name and this business is now undertaking a range of commercialisation activities, both on their own and with key strategic partners, to bring these innovative products to patients around the world. They are currently seeking a Senior Director Regulatory Affairs to join their Dublin based team.

The Position:

  • Provide input into assessments of emerging regulatory trends and precedents as to their potential impact to the business
  • Oversee Regulatory Affairs Department staff and contractors
  • Ensure adherence to Regulatory Affairs budget and achieving company regulatory goals according to agreed timelines and with a high level of quality
  • Support medical affairs and corporate activities, including review of publications and investor relations/legal public disclosures
  • Oversee regulatory aspects of commercial product packaging, labelling and supply for EU countries
  • Provide regulatory affairs project management including timelines and tracking of ongoing regulatory activities and supporting departmental budgeting activities
  • Review key documents (e.g., clinical study protocols, labelling etc) to ensure adherence to regulatory requirements and guidance’s and GCP quality standards
  • Manage submission activities (e.g., IND/CTA and amendments, NDA, MAA, DMF) and health authority interactions (meeting requests and briefing documents), ensuring adherence to regulatory and quality standards and project timelines
  • Provide oversight and management of external regulatory and development vendor resources
  • Serve as a key contact with EMA regulatory project manager
  • Provide oversight of company documents and document systems supporting development activities
  • Support business development activities related to partnering and licensing opportunities and alliance management
  • Management of regulatory affairs aspects of commercial product labelling and supply within the European Union

The Person:

  • Bachelor’s Degree in a scientific or healthcare discipline preferred (advanced degree or relevant certification a plus)
  • At least 5 years’ experience in pharmaceutical regulatory affairs or quality assurance or at least 10 years in pharmaceutical development (e.g., clinical, nonclinical safety) with significant experience in regulatory and/or quality focused activities

To learn more, apply on line or call Shane Browne at HRM on +353 1 6321865.

Salary: On Application Location: Dublin City Centre