Regulatory Affairs Manager (pharma)
|Division||Science, Pharma, Food|
Regulatory Affairs Manager (pharma) - County Waterford.
In this role you will support the Head of Scientific Affairs with activities associated with the registration of products in worldwide markets including US, EU and Japan, as well as Regulatory Compliance liaison with QA for registered products.
You will lead and develop the Regulatory team. Support the Clinical Affairs teams for Regulatory approvals for clinical trials globally as required.
1. Project Planning/Co-ordination
2. Regulatory Compliance
3. Licensing Activities
4. Dossier preparation
5. Strategic planning
7. Recruitment- assist with recruitment of team members in line with resource requirements on to job specification
8. Manage regulatory affairs budget and cost centre activities
Interested applicants should have:
B.Sc. primary degree in Chemistry, Pharmacy or Pharmacology or other Science related discipline considered
At least 10 years' Regulatory affairs experience to include responsibilities in supervisory/people management
Familiarity with cGMP in pharmaceutical manufacturing
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|Contact Interested candidates should forward their CV to firstname.lastname@example.org immediately or call Anthony McLoughlin - Head Office on 01-6321200 for further information.|