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Regulatory Affairs Manager PostApproval

Job LocationMaidenhead
EducationNot Mentioned
Salary£50,000 - £60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Regulatory Affairs Manager, Post-Approval, Life-Cycle Maintenance, Regulatory Submissions, MAA, Renewals Your new companyThis start up generics pharmaceutical company focuses on providing a wide variety of services and products. The company was founded in the last few years and its fresh focus is on IP and manufacturing of specific products that are aimed at a variety of therapeutic areas and operate worldwide. Some of the services they provide include R&D, IP licensing and manufacturing. They have an exquisite site with fantastic facilities based in Maidenhead, and are looking for a Regulatory Affairs Manager to join the team.This company is willing to offer immense career and developmental opportunities to ambitious candidates who are willing to learn and enhance their skill set.Your new roleYour new role as Regulatory Affairs Manager will predominantly focus on post-approval life-cycle maintenance related activities. You along with one other manager will be responsible for ensuring all related Regulatory strategies and submissions are developed. This position will be a combination of working across both the technical and managerial aspects across the team. You will be expected to be hands on in in ensuring all submissions are completed in timely dedicated manners and ensure maintenance of all systems is up-kept. What youll need to succeed

  • Previous experience across Life Cycle Maintenance Regulatory Affairs
  • Strong understanding of MAA applications, Renewals, Variations, and Labelling Updates
  • Experience working with key stakeholders
  • Excellent verbal and written communication skills
  • Experience working with Regulatory eCTD Submissions
  • Strong Leadership qualities
  • Life sciences degree
  • What you need to do nowIf youre interested in this role, click apply now to forward an up-to-date copy of your CV, or call us now.If this job isnt quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. Required skills
  • Renewals
  • Regulatory Submissions
  • MAA
  • Regulatory Affairs Manager
  • Post-Approval
  • Life-Cycle Maintenance
  • Keyskills :
    Renewals Regulaty Submissions MAA Regulaty Affairs Manager Post-Approval Life-Cycle Maintenance

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