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 email@example.com