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Senior Regulatory Affairs Specialist - Romania

IQVIA

IQVIA

Legal
Bucharest, Romania
Posted on Thursday, July 4, 2024

Job Description:

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.

To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

Apply today and welcome to where we thrive together!

The Role:
The Regulatory Coordinator provides high quality and timely operational and compliance support on assigned programs and/or activities through the development, registration and post approval phases. You may also act as a subject matter expert for certain RA systems or processes.

This role works under the supervision of the respective regulatory affairs program team and/ or team lead and is office based.

Major Accountabilities:

  • Provide operational regulatory support for a portfolio of programs, independently coordinating with other groups within RA to finalize and ensure timely dispatch of Health Authority submissions as aligned with assigned program RA sub-teams.
  • Contribute to or lead preparation of assigned Module 1 documents including forms and cover letters with oversight of the RA program lead(s). Support RA sub-team for clinical trial related activities (CTA forms and tracking, transfer of obligations submissions, drug shipment ticket review, etc.).
  • Independently manage assigned regulatory compliance and maintenance activities for clinical trial, registration and post-approval regulatory activities.
  • Ensure tracking and update of relevant regulatory information in compliance systems and trackers as provided by RA sub-team representatives.
  • May act as super-user and/or subject matter expert for selected topics or systems.
  • In some lifecycle management groups, support regulatory activity with a focus on divestment, portfolio rationalization, procurement of samples and certificates, and new product planning.

Your Experience:

  • Bachelors degree preferred.
  • Pharmaceutical industry experience, ideal in regulatory operations.
  • Good interpersonal skills and experience working in a complex, cross functional organization.
  • Fast, flexible and focused on timely delivery. Compliance and quality mindset.
  • Fluency in English and Romanian.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com