EU Compliance Officer

2 days ago


Dublin, Dublin City, Ireland CPL Full time
Role Overview

Thornshaw Scientific's collaboration with global pharmaceutical companies presents an exciting opportunity for a Senior Regulatory Affairs Officer New. This role demands a detail-oriented professional with expertise in EU regulatory affairs. As a key member of our team, you will ensure seamless compliance with EU regulations, contributing significantly to the success of our clients.

Responsibilities:

• Manage EU marketing authorisation dossiers and submissions efficiently, addressing various aspects such as MAAs, lifecycle activities, variations, and transfers.

• Prepare and submit EU regulatory documents, including life-cycle maintenance variations, initial MAA filings, labelling updates, renewals, and marketing authorisation transfers.

• Develop high-quality local modules (e.g., module 1) and administrative documents, adhering to regulatory standards.

• Collaborate with other departments (CMC, clinical) to compile regulatory documentation for DCP, MRP, and national applications within specified deadlines, incorporating responses to queries.

• Establish effective communication channels with European Regulatory Authorities, attend meetings with health authorities as required, and monitor progress on submissions with HA.

Essential Skills:

• Bachelor's degree in Life Sciences or related field.

• Proven track record of 2-3 years in Regulatory Affairs, emphasizing comprehensive knowledge of EU procedures (DCP, MRP).

• Excellent organisational and time management skills, enabling efficient task prioritisation and completion.

• Strong written and verbal communication skills for effective collaboration with global teams.

• Self-motivated individual with excellent multitasking abilities and autonomy.

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