Regulatory Affairs Clinical Trial Manager

Location
Basel Area
Salary
Competitive
Posted
05 Dec 2018
Closes
11 Jan 2019
Ref
896093-P
Discipline
Regulatory Affairs
Contract Type
Contract

Main Responsibilities:

  • Interact with internal departments or teams, affiliates and third parties as required to give regulatory input and guidance for clinical trials and their submission to European and international Health Authorities (HAs)
  • Prepare, submit and maintain Clinical Trial Applications (CTAs) to European and international HAs in accordance with the applicable regulatory requirements
  • Liaise with internal, regional, affiliate and/or CRO personnel to request and collect appropriate documents and, where applicable, to arrange submission
  • Provide advice to Clinical Trial Team members on HA CTA submission processes and other related submissions, such as amendments, End of Trial notifications, etc.
  • For applicable countries, liaise with client’s internal, regional, affiliate and/or CRO personnel to manage submissions related to import/export licenses, including following-up on status of submission and providing input to tracking sheets
  • Final sign-off of IMP Shipment Approval requests for relevant departments
  • Keep country-specific information updated and informs other members of the CTA group accordingly

Qualifications and Experience:

  • At least 3 years experience in Regulatory Affairs within a pharmaceutical company
  • Degree in life sciences preferably
  • Good organizational and communication skills
  • Ability to prioritize tasks and work to deadlines
  • Excellent spoken and written English; knowledge of any other European language would be an advantage
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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