Senior Regulatory Affairs Associate

Description

Senior Regulatory Associate

Responsibilities

• Preparation and review of high quality, Chemistry Manufacturing and Control (CMC) detailed regulatory documents for dossier submission
• Liaising and working closely with other company personnel (R&D, Quality, Business Development and Licensing) to ensure accuracy of such documents Submission of MAAs (generic/bibliographical) in the EU via national, MRP, DCP routes
• Provide regulatory support for out-licensing activities in EU and non-EU territories Auditing registration dossiers for the EU in order to evaluate and identify any possible deficiencies prior to assessment Liaising with Regulatory Authorities and Affiliates Mentoring and daily oversight of Regulatory Affairs Associates and Officers Managing post-licensing activities (variations, renewals, PSURs, etc.)

Skills & Experience

• The role will require you to possess a relevant life science or pharmacy degree
• Minimum of 2 years EU pharmaceutical regulatory affairs industry experience.
• Previous exposure to formulation development, CMC and CTD Dossiers for MAA's is essential.
• You should be an organised, motivated and approachable team player who also works well independently.

Note: If you know anyone that you feel suits this role, please forward this on; we offer generous vouchers if your referral is placed successfully.
For further information, please contact John Lennon on for a confidential chat or else email me on