Regulatory Affairs Manager

Reference No: J8318

Are you seeking to take the next step up in your Regulatory Affairs Career? If so, I have a fantastic opening for a Regulatory Affairs Manager in the European team available with a reputable global pharma company based in Berkshire.

This role will offer the right candidate:

1.A high-profile role with responsibility of managing the regulatory team
2.Experience of working with both established products and new product indications within an European context
3.To work in conjunction with the QA department to develop regulatory strategy and long-term goals for the company
4.A permanent position working with a sought-after pharma company with a fantastic pipeline and who offer the great chance to progress internally
5.A competitive salary and benefits package

***Ideally candidates should have broad Regulatory experience, including carrying out CTA/MAA submissions via MRP, DCP and Centralised Procedure ***

***Previous line management experience is essential as this is a people-management role ***

***Extensive experience of working with European regulatory agencies. Candidates with global as well as EU experience will be highly considered ***

Role responsibilities:
•To provide Regulatory advice and support to European affiliates
•To manage the day-to-day activities of a regulatory team.
•To support the Head of Regulatory Affairs & QA with developing and meeting the longer-term goals for the department.
•To participate in New Product Introductions and ensure that the appropriate regulatory strategy is implemented
•Ensure the registration and regulatory compliance of European products with relevant national and European regulatory requirements
• Ensure the preparation, maintenance and update of product registration/licence and regulatory compliance files.
•Provide regulatory support to the commercial division.

Clinical Professionals are more than just a recruitment agency; we are recognised as the most knowledgeable team in the industry and offer a bespoke service, dependent on your specific needs as a candidate. We are ethical as well as dynamic, honest and passionate about what we do, which enables us to keep a finger on the ever-changing pulse of the pharmaceutical market.

If this position sounds like an ideal fit for your experience and career aspirations, please click on the “apply” button below. Alternatively, if this role is not entirely suitable for you, please contact Lorna at Clinical Professionals directly on 0118 9594990 to discuss other opportunities we am currently recruiting for which may be more of interest.

We also have an excellent referral scheme here at Clinical Professionals. If you refer someone who we then go on to place, you would be eligible for £250 worth of shopping vouchers!

Key words: regulatory affairs reg affairs regulatory manager regulatory senior manager leader MRP DCP CP submissions lifecycle management European EU global emerging markets permanent office-based Reading Maidenhead Slough Marlow Uxbridge Berkshire Middlesex Buckinghamshire Surrey Hampshire relocatable UK

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