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Senior Compliance and Regulatory Manager

3 tygodni temu

Warszawa, Mazovia, Polska ICON plc Pełny etat

About Us

At ICON plc, we believe in the power of innovation and collaboration to drive human health forward. As a world-leading healthcare intelligence and clinical research organization, we're dedicated to creating a brighter future for patients around the world.

We foster a culture of inclusivity, creativity, and growth, where talented individuals can thrive and make a meaningful impact. As a Senior Global Regulatory Affairs Specialist at ICON, you'll be part of a dynamic team that's passionate about making a difference in people's lives.

Job Summary:

We're seeking a seasoned Senior Global Regulatory Affairs Specialist to join our team. The ideal candidate will have expertise in regulatory affairs, clinical trials, and medical data interpretation, with a strong understanding of global regulatory requirements and guidelines.

Key Responsibilities:

  • Coordinate central authority submissions to ensure adherence to contractual timelines.
  • Communicate submission status updates to the Start-Up Lead (SUL) and collaborate to mitigate risks to Sponsor deliverables.
  • Provide the Sponsor and internal Project Team with information on regulations governing the clinical trial at a project level.
  • Address Sponsor queries related to regulatory and submission requirements.
  • Prepare Core Clinical Trial Applications and perform quality control (QC) on central submission packages.
  • Support Business Development efforts by providing regulatory input for Requests for Proposal (RFPs), Requests for Information (RFIs), and participation in Bid Defense Meetings.

What You'll Need:

  • Bachelor's degree in a scientific discipline or related field.
  • Minimum 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
  • Strong understanding of global regulatory requirements and guidelines.
  • Excellent communication skills in English.
  • Ability to work independently and collaboratively in a fast-paced environment.