Overview
Job Title: European Regulatory Affairs Manager
Location: Munich, Germany, Rome, Italy, Madrid, Spain, Amsterdam the Netherlands, and Prague, Czechia Hybrid
Remuneration: Competitive salary and package
Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the small team and lead several Regulatory Affairs activities for an established generics portfolio.
This role will have a main focus on European submissions through MRP, DCP, and National procedures and also support UK and IRE submissions.
The position will be responsible for managing regulatory submissions, new registrations, and variations applications for a range of different generic products marketed in the UK, IRE, and Europe.
Responsibilities
· Manage required regulatory processes for UK and European products including submitting submissions through National MRP and DCP.
· Drive all pre-submission meetings including inputting into scientific advice meetings.
· Be responsible for all initial/new MAA applications into main EU countries.
· Following MA approvals ensure 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.
· Generate and implement local procedures and processes to ensure regulatory compliance is met for EU and UK portfolios.
Requirements
· Bachelor’s degree or higher in Life Sciences or technical field.
· 7 to 10 years of relevant regulatory experience especially within the UK and European markets. Submitting through MRP, DCP and national procedures.
· A strong communicator who is able to navigate through difficult conversations with senior stakeholders.
· Good team working skills, able to influence to achieve objectives.
This position allows for the right candidate to work for a leading generics manufacturer and take charge of UK and European submissions. The role will play a pivotal part in the Regulatory Affairs team and ensure all compliance. The role includes some excellent benefits including a generous bonus scheme.
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