Senior Director / Director, Regulatory CMC Life-cycle / Advanced Therapies

Senior Director, Regulatory CMC. Regulatory CMC Life-cycle maintenance across European & International markets. Additional experience in Regulatory Clinical/Development activity and New Registrations/MAA’s would be ideal.

Top Biotech!! Advanced Therapies (Gene & Cell Therapies) – Rare Diseases

Full Regulatory CMC Pipeline role for a Top Biopharma in London!! Flexible working offered

Regulatory CMC Strategy and Project Leading across Europe. The role is focused on recently launched Products - Orphan Drugs/Rare Diseases.

Are you a Director/Associate Director Regulatory CMC, adept in European & International Regulatory CMC Life-cycle Management activity? If so, this is the opportunity you have been waiting for.

This Senior Director Regulatory CMC role is for a fast-growing and highly successful Biopharma with a portfolio of ‘cutting-edge’ Advanced/Gene Therapy Products; this role will be based in a desirable area of Central London, but flexible working is offered. The role is focused on a variety of Regulatory CMC activity, mainly Post marketing/Life-cycle Management but also including Strategy across Development and Product Registrations

Reporting to The Vice President Regulatory Affairs, you will Project Lead & Advise on European & International Regulatory Affairs Strategy.

Technically, you will have good working knowledge and experience of: Development, New Registrations, Pre and Post approval: IMPD’s & Modules 2.3 and 3, Post Marketing/Life-cycle Management; CTA’s and other Regulatory Development activity: 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.

Ideally, you will have led/participated in Scientific Advice meetings with Regulatory Authorities.

You will collaborate closely with all other key Global Regulatory Affairs stakeholders, including other Global Regulatory Leads, Labelling, CMC Operations, 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 CMC Strategy & Tactics and have good experience in dealing with Affiliates. Ideally, you will have experience of taking Products from 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 12 year's+ solid Regulatory CMC experience including Life-cycle Management, 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 with flexible working arrangements. 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, julian@turnerregulatory.com or by clicking Apply Now.