Senior RA Specialist

Location: Dublin City Centre, Dublin
Salary: Up to €56000 per annum
Posted: about 2 years ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice
Contact name: Sorcha Hayward
Contact email: sorcha.hayward@hrmrecruit.com

Job description

My client are a global clinical pharmaceutical company headquartered in the US. They are focused on the development, approval, and commercialization of specialty products, including a line of generic dermatology products and injectable oncology products. Due to growth and success, they are currently expanding their Dublin operation and seek to hire a Senior Regulatory Affairs professional to join their team on a permanent basis.

The role:

Reporting into the Director of Regulatory Affairs, you will liaise heavily with the U.S arm of the organisation and will be responsible for:

  • Drafting, preparing and reviewing regulatory documentation for EU and international dossier submissions
  • Monitoring progress of registration submissions

The person:

  • Degree qualified in a pharmaceutical/technical discipline
  • 5 years industry experience with relevant technical experience (QA, Tech Ops, R&D, Manufacturing)
  • At least 2 years RA experience
  • Experience with Module 3 CMC authoring
  • Experience with the electronic submission system (eCTD)
  • Understanding of requirements for sterile injectables or drug device combination products desirable

The benefits:

  • Competitive salary
  • Bonus
  • Healthcare
  • Pension
  • Excellent career development and learning opportunities

To find out more, email or call + 353 1 6321866 for a confidential discussion

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