Job Description

Regulatory Affairs Team Leader – Life-cycle Change Management.

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

You will be required to mentor Regulatory Change Leads, 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 largely Pan-European.

An excellent salary package awaits the successful candidate. North West London Location with hybrid working.

Candidates from a Pharma or Biologics background in European Regulatory Life-cycle management with over 7 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.

PharmiWeb.jobs

Job Categories: Marketing manager. Job Types: Contract. Salaries: 40,000 - 60,000 and 60,000 - 80,000.

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