Regulatory Affairs Manager

Overview

Job Title : Regulatory Affairs Manager

Location : Spain - Hybrid / Remote

Remuneration : Competitive salary and package

This position allows for the right candidate to work for a leading business with a wide range of projects and clients. The role will play a pivotal part in the Regulatory Affairs team and ensure compliance. The role includes some excellent benefits, including a generous bonus scheme.

To apply for this role, you must have the full right to work in Spain and be based in Spain, as this employer does not provide sponsorship.

For more information, please contact

Responsibilities

• Manage required regulatory processes for UK and European products, including submitting submissions through National MRP, DCP and CP.
• Drive all pre-submission meetings, including inputting into scientific advice meetings.
• Be responsible for all initial / new MAA applications in the main EU countries.
• Following MA approvals ensures product maintenance, including submission of national variations or notifications.
• Ensure EU and UK product labelling approval and compliance with the MA approval activities.
• Successfully interact with the MHRA and any EU UK Regulatory Authority, ensuring that regulatory processes are completed and products are launched in line with regulatory requirements.
• Work closely with clients to advise on robust regulatory strategy.
• Generate and implement local procedures and processes to ensure regulatory compliance is met for EU and UK portfolios.

Qualifications

Details

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