Director, Regulatory Affairs / Biologics/ATMP's / Regulatory Lead / EU

Director, Regulatory Affairs – Biologics/ATMP/Gene Therapies. Global Regulatory Lead – EU and International. Point of contact with the Regulatory Authorities.

Flexible working arrangements.

This is a sensational Senior Regulatory role: this is a rare opportunity to join a fast–growing and dynamic Biopharma in a great location in Central London; superb role and a career–making challenge.

Product Development in Phases I to III, Registrations and Post marketing activity. Advanced Therapies/Gene & Cell Therapies Product experience desirable. Rare Disease Products/Orphan Drugs. Europe and Global focus. Organise the Team within a Matrix–management environment. High–level Project Leading in addition to Line management of a small team – this role is a combination of Strategy, Development, MAA's, 'hands–on' and people management.

This is a superb senior Regulatory opportunity with significant commercial possibilities. Experience in Advanced Therapies is ideal, along with General Biologics. High–Level Project Leadership skills are vital, along with a background of working knowledge and experience within Regulatory Affairs Strategy, Tactics & Implementation, throughout the Regulatory pipeline. This individual will be responsible for the Regulatory Strategy of several key products hence this is a very important hire. Geographical remit: Europe and International – knowledge of USA/FDA would be beneficial.

Reporting to the VP of Regulatory Affairs, this position also operates as Project Leader with 'dotted–line reports. The candidate will possess an excellent understanding of 'how the industry works', is commercially astute, and have a good perception of how Regulatory issues can impact on profitability.

There are several existing products in the pipeline hence the candidate's responsibilities will encompass taking the assigned products successfully through Late Phases through to successful BLA's/MAA's.

The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a deep understanding of Core Regulatory Affairs in Europe and Internationally. The geographic scope of this role is Pan–European, within the context of Global Regulatory Affairs. The candidate will possess full Regulatory pipeline experience, but with specific strengths in Clinical and Development Regulatory Affairs in Phases I to IV and MAA's/BLA's.

Although there is a small team to manage, the company operates more on a matrix–management model hence the candidate must be prepared to be 'hands–on' and be heavily involved in the day–to–day leading of Projects. The candidate will need to have a substantial background in Development Regulatory, ideally: CTA's, IND's, IMPD's, IB's, Protocols, up–dates/amendments, and End of Trial Notifications – in conjunction with the management of CRO's. CTD/Dossiers for MAA's (overseeing all Modules 1–5); National Submissions/MRP, DCP, and particularly Centralised Procedure; Regulatory Strategy, Tactics, and Implementation; Regulatory Intelligence, Scientific Advice meetings with Regulatory Authorities. PIP's/Waivers and Orphan Drugs.

A demonstrable working relationship with the major Regulatory Agencies and contacts within the EMA and other national Authorities would be an advantage in terms of company representation.

The successful candidate will possess a substantial Regulatory Affairs background within Biologics and ideally ATMP Products of at least 8+ years. The candidate will demonstrate superb management and Project Leading skills along with mentoring of staff and the ability to develop and expand a team when necessary.

This position is based Central London and requires travel as can be expected with a role of this seniority. Flexible working arrangements.

A significant salary package is on offer for the right candidate, this will include a superb basic, LTI's, excellent bonus and numerous other benefits.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on / ; , or , or submit an application by clicking Apply Now.