Regulatory Affairs Specialist

2 days ago


Dublin, Dublin City, Ireland CPL Full time
Job Description

Thornshaw Scientific, a division of CPL Group, collaborates with global pharmaceutical companies to offer rewarding career opportunities. As a Senior Regulatory Affairs Officer New, you will play a crucial role in ensuring compliance with EU regulations.

Key Responsibilities:

• Oversee the management of EU marketing authorisation dossiers and submissions, including MAAs, lifecycle activities, variations, and transfers for our current portfolio of pharmaceutical products.

• Prepare and file EU submissions, encompassing life-cycle maintenance variations, initial MAA filings, labelling updates, renewals, and marketing authorisation transfers.

• Craft local modules (e.g., module 1) and administrative documents, ensuring adherence to regulatory requirements.

• Compile regulatory documentation received from other departments (CMC, clinical) for DCP, MRP, and national applications within assigned timelines, including responses to questions.

• Effectively communicate with European Regulatory Authorities, participate in meetings with health authorities as needed, and follow up on submissions with HA.

Requirements:

• Life Science qualification is mandatory.

• A minimum of 2-3 years of experience in Regulatory Affairs, particularly good knowledge of EU procedures (DCP, MRP).

• Strong ability to multitask and prioritize tasks effectively.

• Effective communication skills with colleagues in global countries.

• Autonomous and self-motivated individual with strong multitasking abilities.

Career Opportunities:

For further information and discussion, please email your CV or contact Linda at the CPL Group.

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