Director, Regulatory Affairs / Global Regulatory Lead / Biologics

Central London/Remote
31 May 2021
30 Jun 2021
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Director, Regulatory Affairs - Global Regulatory Lead - Biologics. Global Regulatory Lead - EU, USA ROW and Japan. 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 but with flexible working arrangements; superb role and a career-making challenge.

Product Development in Phase III, Registrations and Post marketing activity. Biologic Product experience essential. 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 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 General Biologics is required. 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 a key product hence this is a very important hire. Geographical remit: Europe and International - knowledge of USA/FDA would be very desirable.

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 and Post approval.

The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a deep understanding of Core Regulatory Affairs in Europe, USA and Internationally. The candidate will possess full Regulatory pipeline experience.

Although there is a 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; Post marketing activity. 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, FDA and other national Authorities would be an advantage in terms of company representation.

The successful candidate will possess a substantial Regulatory Affairs background within Biologic Products of at least 10+ 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 +44 203 695 9477/+44 1582 290 636; +44 7447 977 330, or, or submit an application by clicking Apply Now.

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