Senior Regulatory Manager / Emerging Markets / ROW - Regulatory Strategy, New Drug Applications & Product Life-cycle / Central London
- Contract Type
Regulatory Strategy, New Drug Applications & Product Life-cycle maintenance in Emerging Markets and ROW - Asia Pacific/Japan, Middle East, CEER/Russia, Africa & LATAM. Top Biopharma in Central London!!
Project Managing and Support across International territories including Asia Pacific/China and Japan, Middle East, Eastern Europe/Russia, Africa and LATAM. Are you a Senior Regulatory Project Manager/Manager, adept in International/Emerging Markets Regulatory Strategy and ‘hands-on’ Regulatory activity? If so, this is the opportunity you have been waiting for. This Senior Regulatory Manager 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 New Product Registrations and Post marketing.
Reporting to The Regulatory Director ROW, you will Project Lead & Advise on International Regulatory Affairs Strategy!! Technically, you will have good working knowledge and experience of: New Registrations and Pre and Post approval: 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. PSUR’s. Ideally, Scientific Advice meetings and PIP's.
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 Regional Strategy is observed and implemented.
You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates Internationally. Ideally, you will have experience of taking Products from Late Phase III, 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 International/ROW 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 Emerging Markets, ROW and International Regulatory Affairs Strategy and Project Management/Leadership with approximately 5-10 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 London location. A 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 +44 203 695 9477/+44 7447 977 330, or firstname.lastname@example.org, or submit an application by clicking Apply Now.