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Senior Manager Regulatory Strategy

Job LocationLondon
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Senior Manager Regulatory Affairs, Regulatory Strategy, Orphan Drug Designations, PIPs, EU Your new companyWith an ever-growing client portfolio, this CRO is unlike any other, distinguishing itself apart from the rest. The company work with many renowned pharmas and biotechs, providing top quality services. The company works to a fast and exciting pace, supporting all up and coming research projects. The company are looking for someone to join in as Regulatory Strategy Senior ManagerYour new roleYou will be joining a Regulatory Strategy team as Senior Regulatory Strategy Manager. The role will entail developing all early stage developmental Regulatory Submissions. This will include submissions across Paediatric Investigation Plans, ODDs, and additional Clinical Development. This will all be directed towards European centralised markets. You will be expected to communicate directly with health authorities as well as cross-functionally with external Regulatory teams (CMC, Labelling, etc). What youll need to succeed

  • Proven expert in Regulatory Submission processes
  • Direct experience in early stage developmental work: ODDs, CTAs, PIPs, MAAs, Scientific Advice
  • EU market submissions
  • Collaborative mindset and working towards larger teams
  • Degree in LS related field
  • Ability to take initiative and hit the ground running approach
  • What youll get in returnBy working with one of the top global CROs, not only are you exposed to a global culture, but you are working across an extremely lucrative client portfolio. Additionally, the opportunity to progress and expand within the company are always present to you, unlike any other.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
  • EU
  • Regulatory Strategy
  • PIPs
  • Senior Manager Regulatory Affairs
  • Orphan Drug Designations
  • Keyskills :
    Regulaty Strategy PIPs Seni Manager Regulaty Affairs Orphan Drug Designations

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