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EU/EMEA Regulatory Affairs Manager

Location: Dublin, Republic of Ireland
Salary: Negotiable
Posted: 3 months ago
Role type: Permanent
Industry: Science Leaders & Specialists
Contact name: Shane Browne
Contact email: shane.browne@hrmrecruit.com

Job description

This commercial stage pharmaceutical organisation focusses on developing and delivering innovative new treatments to help improve the lives of patients with rare or orphan diseases. This organisation is committed to building a diversified portfolio of commercially attractive, best in class, proprietary new drugs to address some of these rare and debilitating illnesses. The organisation's leadership team boasts a wealth of experience in identifying, commercialising and delivering new treatments across global markets and its this success that is driving the organisation's expansion at the business Corporate Offices here in Dublin and the need for a EU/EMEA Regulatory Affairs Manager has arisen to join their growing RA Division.

The Position:

  • Execute the preparation, submission, and approval of major filings in the region
  • Support meetings with the European Medicines Agency
  • Collaborate with EU and global colleagues to ensure unified execution of EMEA regulatory strategy for products primarily for treatment of rare diseases
  • Responsible for preparation and submission of high-quality regulatory dossiers according to agreed timelines utilising cross-functional interactions, excellent project management and writing skills and good understanding of the underlying science
  • Work with Regulatory Operations to ensure appropriate planning, preparation and submission of regulatory documentation
  • Oversee contracted resources throughout the covered region in accordance with objectives and needs
  • Provide input to EMEA regulatory budget planning
  • Participate in multidisciplinary study teams and in global regulatory strategy teams to provide regulatory guidance and communicate EU regulatory requirements
  • Collaborate with regulatory-CMC and manufacturing colleagues to ensure seamless integration of CMC components to relevant submissions
  • Collaborate with and advise EMEA commercial and medical colleagues regarding integration of regulatory and access strategies
  • Contribute to developing and implementing patient-focused regulatory strategy
  • Drive adherence to EU regulations and guidelines
  • Maintain knowledge of EU competitive landscape, EU regulatory policy environment and participate in EU regulatory intelligence activities
  • Develop and direct the activities of EMEA regulatory affairs personnel/external contractors

The Person:

  • Advanced degree in a scientific discipline
  • 5 years + prior experience in product development and post marketing Regulatory Affairs in the biopharmaceutical/pharmaceutical industry, preferably in rare diseases
  • Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) is an advantage
  • Well-versed in regulatory strategy, ICH and EMA guidelines

To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.

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Shane Browne

Director - Science & Engineering

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