Expiry Date: 14-08-2020
Category Regulatory Affairs
Job Type: Full Time
Regulatory / Senior Manager Regulatory Affairs, Central London
We are seeking a Manager / Snr Manager Regulatory Affairs to work closely with an experienced Regulatory Project Lead in providing support to submissions in the EU and direction to the Regulatory strategy.
This role will be expected to give guidance to a range of projects in a range of regulatory requirements both for products in development and marketed products in the portfolio.
This is a permanent role based in Central London, easily commutable from Liverpool Streel, Kings Cross, Victoria, London Bridge, Paddington and Waterloo.
Our client is a global pharmaceutical company with a strong pipeline of over 20 product. Based in London, the EU leads its own development and submission plans and has 3 approved products and 5 in development. The regulatory affairs team consists of 15 professionals, all working in a nice flat structure under the same roof.
In the short-term you will be working in a broad based role in post-marketing regulatory affairs, for 2 recently approved products, but in the longer term as you gain more achievements you will have the opportunity to be involved in new development projects as they come through the pipeline.
You will find many great things about this role, it covers most aspects of post-marketing regulatory affairs, including variations and life cycle management through European procedures and you will be working on global teams that includes the EU, US and Japan. You will also be working on clinical, labelling and PV projects, and you will also receive development opportunities to move into pre-approval projects and/or supporting new MAA’s. So you will have the opportunity to be involved in new development projects as they come through.
Success in this role will require versatility and Regulatory Affairs experience across the whole lifecycle. You will need minimum 3 years of Regulatory Affairs experience. Good knowledge of the European procedures is necessary. You need to have the ability to liaise, negotiate and interact with Regulatory agencies.
In return the package is very competitive and it comes with a bonus, the week has 35 working hours and you can work 1-2 days per week from home, whenever we return to normality. Meanwhile, our client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.
To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384. All applications are received in confidence! ADV Talent Partners will help you each and every step of the way through the hiring process!
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