Regulatory Affairs Specialist

This global healthcare leader employs upwards of 40,000 staff globally with a product portfolio sold in over 100 countries worldwide. This business is continuously expanding their Irish operations and as a result, a new requirement for a Senior Regulatory Affairs professional has arisen for one of their Munster operations (GMP facility). One of the most reputable companies in Ireland and worldwide, this company offers excellent career opportunities for driven Regulatory/Compliance talent.

The Role:

Reporting to the Regulatory Affairs Manager you will have responsibility across the following:

  • Overseeing the preparation and documentation of specified regulatory submissions
  • Providing regulatory leadership and direction for products listed as primary responsibilities
  • Managing submission timelines, monitoring approval status and communicating change status to interested personnel in a timely manner
  • Providing the necessary CMC commitment information to site personnel
  • Reviewing and/or approval of regulatory changes, regulatory deviations, proposals for reprocessing, validation and stability protocols

The Person:

  • Minimum of an undergraduate degree, ideally an advanced degree (MS or PhD preferred), in related biological and life science field
  • 5+ years’ direct industry experience – Pharma / Medical Device / Biotech
  • 3+ years’ experience within a Regulatory or Compliance function. Strong knowledge of regulatory and compliance guidelines within manufacturing
  • Eligible to work and live within the EU

The Benefits

  • Excellent training
  • Competitive annual salary
  • Annual performance onus
  • Family healthcare plan
  • Pension contribution scheme
  • Parking
  • Canteen

To discover more about this opportunity, apply now or contact Ciara O’Brien at HRM on +353 1 632 18 55 for a confidential discussion.

Salary: On Application Location: Cork