REMOTE WORKING / Director, Regulatory CMC / Biotech / Strategy, Development & Lifecycle

Director, Regulatory CMC – Fast-growing Biotech.

Leadership, Strategy, Development, Registrations and Lifecycle management. Lead Scientific Advice meetings.

Exciting Regulatory CMC position: this is a rare opportunity to join a fast-growing and dynamic Biopharma in a fantastic location in Central London; superb role. Regulatory CMC Development in Phases I, II to III, Registrations and some Post marketing activity. General Biologics is essential and some ADTHER experience highly desirable. Rare Disease Products/Orphan Drugs. Europe, USA, and international focus. Matrix-management environment. Project Leading – this role is a combination of Strategy, Development and ‘hands-on.’

Reporting to the VP Regulatory CMC, this is an excellent Regulatory CMC commercial opportunity with significant possibilities. Experience in Biologics is essential for this role. Project Management skills are vital, along with a background of working knowledge and experience within Regulatory Affairs Strategy, Tactics & Implementation, throughout the Regulatory pipeline. Geographical remit: Europe and International/USA.

There are a number of existing products in the pipeline hence the candidate’s responsibilities will encompass taking the assigned products successfully through Phases I, II and III through to successful BLA’s/MAA’s.

The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a good understanding of Core Regulatory Affairs, particularly in Europe. 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 Development Regulatory Affairs in Phases II to IV.

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 management of Projects. The candidate will need to have a substantial background in both Strategy and Development Regulatory, ideally: IMPD’s (CMC section); CTD/Dossiers for MAA’s (authoring Modules 3 and 2.3); Post Marketing/Lifecycle Management: Type Ia, Ib and II Variations, Renewals, and Line extensions. EU procedures – particularly Centralised Procedure & BLA’s; Regulatory Strategy, Tactics, and Implementation; lead Scientific Advice meetings with the EMA and FDA.

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 solid Regulatory CMC background within Biologics of at least 8-10 years. The candidate will demonstrate superb Project Management skills.

This position is based Central London with flexible working, and may require some travel, as necessary.

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

If you are interested in this, or any other Regulatory Affairs roles, please contact Julian Turner, at Turner Regulatory Recruitment, on +44 203 695 9477/+44 1582 290 636; +44 7447 977 330 or apply by clicking Apply Now.

 

 

 

Some Of Our Feedback

  • A fast-growing Biotech Company were struggling to find a Vice President, Global Regulatory Affairs and having engaged a major Executive Search firm in the USA had spent over 1 year looking for the right candidate without success. Within 8 weeks of requesting my help, we provided the company with 12 candidates, from which the ideal candidate was selected, who, over two years on, is still successfully operating within this role.

  • A leading Biopharma Company were looking for an Associate Director, Regulatory Strategy Team Lead for Emerging Markets, but had thus far failed to secure the right candidate. In fact, after 6 months of trying they’d only been able to secure an interview with one, less than ideal, candidate. Within 30 days of working with myself, a very suitable candidate was identified and started working for the company within 3 months. We provided the Biopharma Company with 11 excellent candidates to choose from.

  • A Pharmaceutical Company contacted me to find their new Head of Regulatory Affairs, to be based in a challenging location. Within 60 days of approaching me, after an intercontinental recruitment campaign, 6 candidates were identified and delivered. A suitable candidate was chosen and placed. The Company expressed their gratitude for having exceeded their expectations.

  • A newly created Vaccines organisation tasked Turner Regulatory Recruitment with finding a Head of Region, Senior Director, EU Regulatory Affairs. At the time, there were a number of Biotech/Vaccines companies seeking to fill similar positions; however, in spite of these challenging market conditions 13 candidates were identified and put forward from the ensuing short-listing process, one particular candidate was chosen, offered and accepted; this candidate is still happily in situ.

  • A well-established and commercially successful Biotech Company was having trouble in sourcing a Senior Director Regulatory CMC with a European/EMEA focus for their London Office. This organisation had been seeking to fill this role using numerous Agencies/Head-hunters for well over 6 months without success. Turner Regulatory Recruitment took a fresh and targeted approach to the role, identifying and delivering 8 excellent candidates. From the following interviewing process, not 1, but 2 candidates were offered, and both accepted.