Associate Director, Regulatory Strategy - Emerging Markets

Recruiter
Turner Regulatory Recruitment ltd
Location
London (Central)
Salary
£80,000-90,000 car allowance, good bonus, benefits
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Regulatory Strategy and Team Leadership in International/Emerging Markets. Top Biopharma in Central London!!

Associate Director, Regulatory Strategy for a top Biopharma in London!! Team Leadership and Project Leading across European, and particularly International territories including China and Japan and the Middle East. Are you a Senior Regulatory Project Manager/Manager, or perhaps already an Associate Director, adept in European and International/Emerging Markets Regulatory Strategy? If so, this is the opportunity you have been waiting for. This Associate Director, International Product Lead role is for a fast-growing and highly successful Biopharma with a significant portfolio of products; this role will be based in a desirable area of Central London. The role is focused on a variety of Regulatory activity, including Strategy across Development in Early and Late Phases, New Product Registrations and Post marketing.

Reporting to The Head of International Regulatory Strategy Group, you will Project Lead & Advise on European and International Regulatory Affairs Strategy!! Technically, you will have good working knowledge and experience of: Clinical/Development Regulatory Affairs, Registrations and Post approval: CTA's and other Development Regulatory activity, CTD/Dossiers for MAA's; National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. Scientific Advice meetings and PIP's. Orphan Drugs.

You will collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Global Regulatory Leads, Labelling, CMC, Regulatory Operations, European Regulatory Teams and Regulatory Affiliates, in order to ensure that all aspects of the Regional Strategy is observed and implemented.

You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates throughout the EU and Internationally. Ideally, you will have experience in taking products through Early and Late Phase, through to successful Registrations and Post marketing. You will be required to interface with Commercial Teams and will operate as the primary interface with European and International Affiliates across numerous Therapeutic Areas. You will possess good commercial awareness and an excellent eye for detail.

Candidates from a Pharma, Biopharma, or perhaps a CRO background, in European and International Regulatory Affairs Strategy and Project Leadership, and with approximately 8-12 year's 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 London location. A certain amount of Travel will 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 the number provided, or by Email, or submit an application by clicking Apply Now.