Regulatory Affairs and Quality Manager

3 days ago


Helsinki, Uusimaa, Finland Santen Pharmaceutical Co. Full time

Our Commitment:

We strive to create an environment where our employees can grow and develop professionally, while making a meaningful contribution to our mission.

Job Description:

This role will provide direct support to the Head of Global Clinical Quality (CQA) and Pharmacovigilance Quality Assurance in managing compliance related to cGCP, pharmacovigilance, and other related activities.

Main Objectives:

  • To support the development of quality processes and systems to ensure compliance with clinical study-related activities.
  • To collaborate with contract research organizations and in-house clinical development to design Clinical QA folders for all development studies.
  • To support preparations for and follow-up of effective audits of investigator sites, essential documents, Trial Master Files, vendors, and internal processes.
  • To provide effective oversight of systems cross-functionally in clinical research and development.
Responsibilities:
  • Support continuous improvement of quality processes and systems that ensure compliance with clinical study-related activities.
  • Design Clinical QA folders for all development studies that are easy to navigate and identify.
  • Support preparations for and follow-up of effective audits of investigator sites, essential documents, Trial Master Files, vendors, and internal processes.
  • Provide effective oversight of systems cross-functionally in clinical research and development.


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