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Regulatory Submission Expert

1 tydzień temu

Warszawa, Mazovia, Polska TN Poland Pełny etat
About the Role

We are seeking a highly skilled Regulatory Submission Expert to join our team in Warsaw, Poland.

As a Regulatory Submission Expert, you will be responsible for ensuring that all regulatory submissions are accurate, complete, and submitted in a timely manner.

  • Preparing regulatory submissions (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, etc.)
  • Collaborating with quality lines and relevant project team subject matter experts to ensure the accuracy and quality of information presented in assigned documents

Our ideal candidate will have a strong background in life sciences and experience working with regulatory submissions. You will have excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely, and persuasively.

About Us

Pfizer is a global leader in healthcare with a commitment to innovation and patient-centricity. We are driven by our purpose to deliver breakthroughs that change patients' lives.

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work-life harmony, attracts talent, and enables everyone to be their best working self.