Senior Regulatory Affairs Manager

3 weeks ago

London, United Kingdom Cpl Healthcare Full time

Job Title: Senior Regulatory Affairs & PV Manager
Employment Type: Permanent position
Hybrid)
Remuneration: Competitive salary and package
Senior Regulatory Affairs & PV Manager opportunity working for a growing pharmaceutical company specialising in medicinal, non-medicinal, medical devices, and OTC products. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the team and lead the RA and PV Team (4 individuals).
You will be responsible for managing regulatory submissions, MA Transfers, Initial MAA’s, new registrations, and variations applications.
Manage required regulatory processes for UK and European products including submitting submissions through National MRP and DCP.
· Define, develop, and leads regional strategies to maximize regulatory and pharmacovigilance success.
· Oversight a team of 4 to ensure day-to-day activities are carried out in Regulatory and Pharmacovigilance.
· Drive all pre-submission meetings including inputting into scientific advice meetings.
· 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.
Bachelor’s degree or higher in Life Sciences or technical field.
·5 to 10 years of relevant regulatory experience especially within the UK and European markets. A strong communicator who is able to navigate through difficult conversations with senior stakeholders.
· This position allows for the right candidate to work for a growing pharmaceutical company and take charge of UK and European submissions. The role will play a pivotal part in the Regulatory Affairs and PV team and ensure all compliance. The role includes some excellent benefits including a generous bonus scheme.

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