Regulatory Affairs Expert

2 weeks ago


Malmo, Skåne, Sweden TN Sweden Full time

TFS HealthScience is a leading Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.

Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.

We are currently looking for a Regulatory Affairs Manager with global clinical expertise in regulatory affairs.

The role involves working operationally on preparing, conducting and completing Regulatory Affairs tasks in assigned Study Teams, according to company policies, SOPs and regulatory requirements.

This freelance role requires a commitment of 1–2 days per week, and the candidate is expected to work on-site in an office.

Key Responsibilities
  • Provide regulatory services to support international multinational clinical trials.
  • Prepare, review, and compile regulatory submissions.
  • Liaise with regulatory authorities and provide expert advice on regulatory questions/issues.
  • Maintain electronic files and regulatory trackers as required.
  • Submit and support clinical trial applications to regulatory authorities within the EU.


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