A B Resourcing has been appointed to recruit a Senior Regulatory Affairs Associate on behalf of this global organization based in the West Midlands.

The main function of the role is to obtain and manage marketing approvals and product licenses throughout the business's operational areas within EMEA.

Day to day, the role consists of  the management of European and world wide regulatory projects, preparation of registration strategies as appropriate, advising and determining  appropriate action for proposed manufacturing/license changes, preparing and submitting product license applications, preparing and submitting variations to approved product licenses, preparing and submitting applications to renew product licenses as necessary, ensuring compliance with new regulatory requirements as they are issued/updated by the regulatory authorities, responding to requests for technical support from regional offices and local distributors as required, reviewing production changes against registered information throughout EMEA region, to allow batch release, ensuring all internal documentation is compliant with registered particulars, maintenance of databases relating to regulatory activities, liaising with Regulatory Agencies and the labelling group to generate appropriate packaging materials.

The successful candidate will hold a degree in Pharmacy or Life Sciences, have an organised and systematic approach to work with good time management skills, have excellent  analytical skills, be a creative thinker, be able to work well individually and as part of a team, be proactive  with high personal energy, and have superb communication skills.

You will likely have at least 3 years experience in a similar role.

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