AX-7148 Senior Regulatory Affairs Manager (UK & Ireland)
New position within an established Pharma Company to lead their UK and Ireland Regulatory operations. This will include activities relating to pipeline assets, business development and new marketing authorisations as well as post-approval regulatory activities associated with the commercialised product portfolio. Additional responsibility will be ensuring credible and long-term partnerships both internally and with vendors. Office based in Cambridge- some flex for home working – strong package.
Established Pharma Organisation – strong portfolio
Stand-alone UK & Ireland position
Office based in Cambridge with flexibility for some home working
Some travel but relatively light.
As Senior Regulatory Affairs Manager, responsibilities will include managing and overseeing UK and Ireland specific regulatory activities relating to pipeline assets, business development and new marketing authorisations as well as post-approval regulatory activities associated with the commercialised product portfolio. Additional responsibility will be ensuring credible and long-term partnerships with internal and external stakeholders around all aspects of regulatory activities as related.
This position will also see you ensuring that marketing authorisations (MAAs) are secured according to the needs, that existing MAAs are maintained according to relevant regulatory requirements and business priorities as well as providing regulatory direction and support to product launch and commercialisation activities including artwork, labelling etc.
You’ll ensure that registration applications and deliverables are of a high standard, aligned with business priorities and that there is timely strategic input and consideration for UK and Ireland needs to development and regulatory plans for pipeline assets
Ideally, you’ll have a working knowledge of the UK/Ireland pharmacovigilance environment in order to support the Pharmacovigilance function and liaise with the European PV team – however this a desirable over an essential.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Educated to degree level (Bachelors or Masters) in a relevant discipline.
A proven regulatory strategist with a successful track record of ensuring business success in an affiliate position and specifically within UK and Ireland.
Established credibility with regulatory agencies with excellent negotiation skills and demonstrable success in influencing HA positions to ensure positive regulatory outcomes.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
Very competitive, including a flexible pot and additional bonus.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.
To apply, please click APPLY ONLINE.
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