Regulatory Affairs Specialist

Job description

My client a Waterford based pharma facility has a vacancy for a Regulatory Affairs Specialist.

Key duties will include (but not limited to) :

  • Provide regulatory CMC filing support for assigned projects/products.
  • Provide required CMC submission activities (planning, obtaining required data, coordination etc..
  • Authoring, reviewing and submitting documents.
  • Duties done in accordance to regulatory requirements and project timelines
  • Respond to health authority questions or local subsidiary requests for additional information.
  • Continious support CMC regulatory filing
  • Works with moderate work direction and is skilled and knowledgeable to the position. 

The is a senior position and the salary would reflect such.

CMC regulatory experience is essential.

For more information please call Colin on 021-4847131 or E-Mail