Clinical Research Specialist

4 days ago


Malmo, Skåne, Sweden TN Sweden Full time

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

We are currently looking for a Global Regulatory Manager to join our SRS/FSP team, dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in different Therapeutic Areas.

Key Responsibilities
  • Provide regulatory services to support international multinational clinical trials in accordance with client requests.
  • 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.
  • Develop regulatory documents for clinical trial submissions and scientific advice meetings.
  • Act as a Project Lead for regulatory-only projects when required.
  • Provide regulatory strategy and guidance to sponsors and internal teams to ensure compliance with regulations.
  • Participate in meetings, share regulatory intelligence, and contribute to continuous improvement initiatives.
  • Assist in the development and maintenance of department SOPs and tools.
  • Stay updated on international regulatory requirements and procedures.
  • Provide training and supervision to new regulatory personnel.


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