Regulatory Affairs Manager, Lifecycle management – 12 month Fixed-term Contract

Regulatory Affairs Manager – 12 month Fixed-term Contract

Regulatory Affairs Manager – Lifecycle Change Management. Are you already a Regulatory Project Manager ready to take the step-up to Manager? If so, this is the opportunity you have been waiting for. This Regulatory Affairs Team Leader, Life-cycle Management, is for a fast-growing Specialist Pharma Company in the Middlesex/Northwest London area; this organisation has a highly successful established product portfolio and is expanding into new Therapeutic areas.

Pan-European and Commonwealth Countries in geographic scope.

You will be required to mentor Regulatory Staff, and Project Lead and Manage. You will be responsible for the Life-cycle Team with particular emphasis on Changes. Managing the Regulator Change Leads, you will ensure prioritisation, planning and execution of Post Marketing activity across the Product Portfolio. You will liaise with Regulatory Managers and Service providers to ensure effective implementation and effect plans to harmonise how Regulatory Projects are managed and improved.

Technically, you will have good working knowledge and experience of Registrations and Post marketing activity/Life-cycle management; CTD/Dossiers for MAA’s (ideally, all Modules 1 to 5); National Submissions/MRP, DCP and Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals; Labelling, PIL’s and SmPC’s. Your geographic scope will be Pan-European and some International territories.

An excellent salary package awaits the successful candidate – £70,000+ basic, 15% Bonus and leading benefits. Northwest London Location – flexible working.

Candidates from a Pharma or Biologics background in European & International Regulatory Life-cycle management with over 8+ years’ experience, and good mentoring skills should be suitable for this position. You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on 0203 695 9477/07447 977 330 or 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.