RA Submissions Manager

Location: Dublin South, Dublin
Salary: €45000 - €51000 per annum
Posted: about 2 years ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice, Science Leaders & Specialists
Contact name: Sorcha Hayward
Contact email: sorcha.hayward@hrmrecruit.com

Job description

A globally recognised healthcare organisation specialist in high volume manufacture and production of topical and solid dose products are seeking to appoint a Regulatory Affairs professional to join their Regulatory Affairs team.

The Role

Reporting to the Senior Regulatory Affairs Team Lead, you will act as Project Manager to facilitate the delivery of submissions within a specific product portfolio. You will be monitoring performance progress and communicating such with relevant stakeholders. In addition, you will also be responsible for:

  • Life cycle management to ensure sufficient pipeline
  • Authoring and reviewing module 1 documentation
  • Governing repsonses to health authority queries and deadlines
  • Ensuring specific management systems are up to date in accordance with quality and compliance standards

The Person

The ideal candidate will:

  • Be degree qualified in a relevant discipline
  • Have 3+ years' working experience within regulatory affairs
  • Possess knowledge of submission strategies

For more information about this opportunity apply online or contact Sorcha Hayward directly on +353 1 6321866 for a confidential discussion.

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