- Licence maintenance support to customers, Regulatory agents and internal departments
- Regulatory Compliance liaison with QA
- Support licensing activities for existing Marketing Authorisation applications in Europe, US, Japan, Canada and various markets in South America, Asia and the Middle East
- Dossier preparation for submission to all target markets, including liaison with R&D, QC, and Production as well as external experts where required
- Strategic planning of regulatory activities in target markets for products (human and veterinary; solid oral dosage forms, fill finish and inhalations)
- Support activities in the areas of Bio-equivalence and Clinical safety and efficacy study management
Qualifications and Experience Required:
- Minimum B.Sc. or a third level qualification required, preferably in Chemistry, Pharmacy or Pharmacology.
- Previous pharmaceutical experience required; 1-2 years regulatory affairs experience desirable.
- Familiarity with cGMP in pharmaceutical manufacturing.
- Familiarity with concepts of Regulatory Approval process for both new drug developments (human and veterinary), and human generic pharmaceutical products.
- Technical knowledge of analytical/formulation development of pharmaceutical products including solid oral dosage forms (tablets, hard capsules, soft gel capsules), fill finish (biologics and small molecules) and inhalations.
- Working knowledge of EDMS (Electronic Document Management System).
- Competent in the use of Microsoft office.
For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie