Regulatory Affairs Manager - USA

  • East of England/Anglia,North East,North West,Yorkshire and Humber,East Midlands,West Midlands,London,South East Coast,South Central,South West,Scotland,Wales,Republic Of Ireland,Northern Ireland,Western Europe,USA
  • Highly competitive salary & package in line with experience
  • Ref: 7404

About the Job

Title: Senior Regulatory Manager
Location: Based in the United States
Salary: Highly competitive salary + exceptional benefits on offer
Ref: 7404

A brand-new opportunity with a privately-owned healthcare company, as they continue their growth across into the US with a leading Woundcare portfolio!

Interested? Please get in contact with us on 0113 457 0777 to speak to a member of the team!

Role Responsibilities

  • Responsible for the creation, assembly, and publication of U.S. FDA submissions related to drugs and maintenance of these approvals.
  • Regulatory project work and timeline planning.
  • Adherence to required submission timelines, health authority publishing specifications, relevant legislation and internal working practices.
  • Liaison with several departments in order to ensure that documents are compliant and submission ready. Work with document authors to ensure that documents comply with current U.S. FDA regulatory guidance/template specifications.
  • Provision of feedback to your line manager regarding submission progress.
  • Ownership of the CTD’s submission.
  • Ownership of the first eCTD within the CDER division of the FDA.

Apply For Regulatory Affairs Manager - USA

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