Regulatory Officer - Compliance
As the new Regulatory Compliance officer, you will report to the Regulatory Manager and Manage new applications, Variations and maintenance of International MA's. You will support new product introductions Internationally and gap analysis of international CMC documentation. You will assist with development of international Regulatory strategy and regulatory intelligence.
As part of the remit, you will also,
- Compile and deliver hard copy or eCTD of MA dossiers for requesting country(s)
- Review CMC dossier packages for accuracy, completeness and compliance
- Actively participate in assigned projects by providing regulatory guidance.
- Liaise with appropriate stakeholders to resolve issues surrounding successful dossier build.
The ideal candidate will be degree qualified in life sciences or Pharmacy degree. You will have 1-2 years experience working in a regulatory Affairs environment along with relevant experience in, and general knowledge of, pharmaceutical industry.
As part of the individual requirements, you will also have:
- Knowledge of EU and other regions current registration of dossier requirements.
- Knowledge of how to source registration requirement information.
- Experience with RA and QA pharmaceutical systems
Competitive benefits Package
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales