Regulatory Affairs Manager. Regulatory Strategy, Regulatory Development, New Drug Applications with some Product Life-cycle maintenance across European markets. Top Biopharma in Central/West London!!
Regulatory Strategy and Project Leading across Europe. The role is focused on 2 Therapeutic Areas.
Are you a Regulatory Project Manager/Senior Associate, adept in European Regulatory Strategy and ‘hands-on’ Regulatory activity? If so, this is the opportunity you have been waiting for.
This Regulatory Manager role is for a fast-growing and highly successful Biopharma with a portfolio of ‘cutting-edge’ products; this role will be based in a desirable area of Central/West London. The role is focused on a variety of Regulatory activity, including Strategy across Development, New Product Registrations, and some Post marketing.
Reporting to The Director, Regulatory Affairs, you will Project Lead & Advise on European Regulatory Affairs Strategy.
Technically, you will have good working knowledge and experience of: Development, New Registrations, Pre and Post approval: CTA’s and other Regulatory Development activity – IMPD’s, IB’s, Protocols, up-dates/amendments and End of Trial Notifications; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and particularly Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. PSUR’s.
Ideally, you will have participated in Scientific Advice meetings and PIP's/PIP Waivers. Orphan Drugs/Rare Diseases.
You will collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Global Regulatory Leads, Labelling, CMC, Regulatory Operations, other Regulatory Teams and Regulatory Affiliates, in order to ensure that all aspects of the European Strategy is observed and implemented.
You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates. Ideally, you will have experience of taking Products from Early & Late Phase, through to successful New Registrations and Post marketing.
You will be required to interface with Commercial Teams and will operate as the primary interface with Affiliates across assigned Therapeutic Areas. You will possess good commercial awareness and an excellent eye for detail.
Candidates from a Biopharma, Pharma or perhaps a CRO background, in European Regulatory Affairs Strategy and Project Management/Leadership with 5 year's+ solid experience, should be suitable for this position.
Superb organisation - a top employer with outstanding products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate.
Desirable Central/West London location which is also convenient for those who live West of London in Berkshire. Some Travel may be required in this role.
If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on 0203 695 9477/07447 977 330, email@example.com or by clicking Apply Now.