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Senior Manager – Global Regulatory Strategy Project Lead, CTA’s/Clinical Development (emphasis), MAA’s & Lifecycle management

Senior Manager – Global Regulatory Strategy Project Lead, Clinical Development, MAA’s & Lifecycle management

The Senior Manager – Global Regulatory Strategy Project Lead will have an emphasis on CTA’s, IND’s & Clinical Development in Phases I to IV. Clinical/CTA Regulatory, ‘hands-on’ and Project Leading in European, USA and International Markets – Pharma Products.

Experience in CTD/Dossiers for MAA’s, European Procedures: National Submissions/MRP, DCP and Centralised Procedure; Post Marketing: Type Ia. Ib and II Variations and Renewals; Labelling PIL’s and SmPC’s.

This role will have responsibility for Managing and Leading projects and mentoring a small team.

This is a hands-on and strategic role – current ‘hands-on’ CTA/IND/Clinical activity is essential for this role. Experience in Scientific Advice meetings with the Regulatory Authorities, Orphan Drugs/Rare Diseases and PIP’s/Waivers are beneficial.

Hybrid working is possible for this position. Yorkshire or Berkshire locations.

Full Clinical/Regulatory Pipeline exposure is required from initial CTA’s (first-in-man) through to End of Trial Notifications. The geographic scope of this role is Global: Pan-European, USA & International territories. Good working knowledge of Pharma Products. This role reports to the Director.

Phases I to IV: Clinical/Development Regulatory Affairs: CTA’s, IND’s, IMPD’s, IB’s, Protocols, updates/amendments and End of Trial Notifications/other Development Regulatory activity, Scientific Advice meetings and PIP’s. Orphan Drugs.

You will have experience across numerous Therapeutic Areas.

You will possess good commercial awareness, a good understanding of how the business works, and how Regulatory matters can impact on ‘the bottom line.’ You will have and an excellent eye for detail.

Candidates from a CRO, Biopharma or Pharma background, in European & International Clinical Regulatory Affairs with over 6+ years’ experience and team mentoring skills should be suitable for this position.

Excellent salary package – circa £70,000-£80,000 basic, bonus, car allowance and other leading benefits. Joining this successful Pharma represents a significant commercial opportunity. Hybrid working offered from two locations.

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 7447 977 330, or by 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.