Senior Regulatory Affairs & PV Manager

Job Title: Senior Regulatory Affairs & PV Manager

Employment Type: Permanent position

Location: East London, 3 days on site. (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).

This role will have a main focus on UK and  European submissions through MRP, DCP, and National procedures managing over 150 licenses. You will be responsible for managing regulatory submissions, MA Transfers, Initial MAA’s, new registrations, and variations applications.

Responsibilities

·       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.

·       Sound knowledge of requirements of MA Transfer in EU territories, which includes requirements of notarization and translations.

·       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.

·       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.

·       5 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 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.

To apply for this role you must have the full right to work in Europe as this employer does not provide sponsorship. For more information please contact lucy.kirkaldy@cpl.com