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Manager Regulatory CMC / ROW / Emerging Markets / Leading Biopharma

Manager Regulatory CMC / ROW / Emerging Markets / Leading Biopharma

Exciting Regulatory CMC role: this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location with some Hybrid Working. New Registrations (new launches) and Post approval. Regulatory CMC – Modules 2.3 and 3 Authoring. ROW/Emerging Markets – LATAM, Africa, Middle East, Asia/Pacific; some European filings. All National Submissions.

This is an excellent Regulatory CMC opportunity with significant possibilities for advancement within this exciting organisation. Experience in Biologics is desirable but not necessarily essential for this role. Project Management skills, along with a background and working knowledge of Regulatory Affairs Strategy, Tactics & Implementation, throughout Regulatory CMC Development and Registration.

The candidate will have expertise in Regulatory CMC Strategy, Tactics and Implementation and have a good understanding of Core Regulatory Affairs, particularly in ROW/Emerging Markets. The candidate will possess good Regulatory CMC pipeline experience, but with specific strengths in New MAA’s and Post approval – IMPD’s and Module 3 Authoring, Variations, etc. All National Submissions.

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 Regulatory Strategy, ideally: CTD/Dossiers for MAA’s (Module 3 and 2.3 writing); National Submissions; Regulatory Intelligence exposure and Scientific Advice meetings would be beneficial.

The successful candidate will possess a solid Regulatory CMC background within Pharmaceutical or Biologics or of at least 5+ years. The candidate will demonstrate solid Project Management skills.

This position is based in Cambridge, and may require some travel, as necessary. Hybrid working is permitted.

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 get in touch with Julian Turner, at Turner Regulatory Recruitment, on +44 203 695 9477/+44 1582 290 636; +44 7447 977 330, or julian@turnerregulatory.com, or submit an application 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.