4 months ago
Job title: Regulatory Affairs Associate - Steriles - European Generic Registration
A global pharmaceutical company in Essex are seeking an experienced regulatory affairs individual to join their EU submissions team. This role will focus on Steriles within the European markets.
- Manage new MAAs submitted via Decentralised (DCP), Mutual Recognition (MRP) and Centralised (CP) procedures.
- Work closely with line manager to coordinate preparation of high-quality dossiers, which fulfil regulatory requirements and Health Authority (HA) expectations.
- Where requested, review third party dossiers and with line manager identify risks and communicate RA input on approvability to other team members.
- Keep up to date on regulatory trends in the EU Region.
- Provide central RA support to EU countries, CA, CH and International Markets.
- Pharmacy/Chemistry or Life Sciences degree.
- Knowledge of regulatory requirements, process, procedures, & pathways.
- Experience in Sterile/Complex Generics is essential
- Prior EU Regulatory experience would be advantageous
Salary and benefits:
A competitive annual salary and benefits scheme is on offer with this role
To apply for this position or hear further details then please contact Matt Thomas via email@example.com