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Regulatory Affairs Senior Associate - London, United Kingdom - Cpl Life Sciences
Description
Job Title:
Senior Regulatory Affairs Officer (Maternity Cover)
Location:
North London, UK - (Hybrid)
Remuneration:
£40,000 - £46,500Senior Regulatory Affairs Officer 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.
Please note that this is a 12-month fixed-term contract and will be looking for the right person to start this position in July/August 2024.
The position will be a maternity cover FTC and you 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.
ResponsibilitiesManage required regulatory processes for UK and European products including submitting submissions through National MRP and DCP.Support all pre-submission meetings including inputting into scientific advice meetings.
EU and UK product labelling approval and compliance with the MA approval activities.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 A degree or higher in Life Sciences or technical field.4 to 8 years of relevant regulatory experience especially within the UK and European markets.
Strong communicator who is able to navigate through difficult conversations with senior stakeholders.The role will play a pivotal part in the Regulatory Affairs team and ensure all compliance.