Regulatory Affairs Associate - Steriles - EU Generic

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.

Responsibilities:

• 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.

Requirements

• 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 matt.thomas@pharma-partners.co.uk