Regulatory Affairs Professional – Cork

This global health care 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 offer 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 Bonus
  • Family healthcare plan
  • Pension contribution scheme
  • Parking
  • Canteen

To learn more, apply online or contact Gillian McMurrough directly on +353 1 6321827 for a confidential discussion.

Salary: On Application Location: Cork