Strategic Coordinator for European Regulatory Affairs

2 semanas atrás


Lisboa, Lisboa, Portugal Phiture Tempo inteiro

About the Role

We are seeking a highly skilled Strategic Coordinator for European Regulatory Affairs to join our team. As a key member of our Regulatory Excellence team, you will play a crucial role in ensuring continuous improvement of end-to-end processes and driving proactive solutions regarding automation, digitalization, or simplification.

Your Key Responsibilities

  • Maintenance and optimization of existing SharePoints (over 10) with creation of new SharePoints when needed.
  • Prepare and manage all training for PLM Portal, optimizing workflows for the EU platform to meet CHC needs.
  • Weekly meetings with PXL to control, explain, and improve workflows.
  • Veeva reports creation and maintenance, managing Article 23 reports and setting up a workflow for local notification.
  • Manage CmdH notifications, including upcoming WS from the SRF extract.
  • C coordinate renewals preparation for MRP/DCP, integrating the way of working into the EU platform.
  • Execute regulatory intelligence of EMA website/PLM portal and attend necessary meetings from EMA regarding implementation and shortages notification portal ESMP.

About You

  • Bachelor of Science or equivalent required in science or engineering; Master of Science preferred.
  • A minimum of 5 years in pharmaceutical industry with demonstrated experience in European regulatory affairs.
  • Good level of understanding of regulatory procedures and E2E processes.
  • Ability to think strategically and translate business and technical objectives into roadmaps, projects, and data strategies.
  • Collaborative approach and ability to cooperate transversally and drive change in Regulatory.
  • Excellent interpersonal skills, negotiation skills, and verbal and written communication abilities.
  • Ability to lead and drive in a fast-paced team environment and thrive in a global team environment.

What We Offer

  • An estimated salary of $80,000 - $120,000 per year, depending on experience.
  • A comprehensive rewards package that recognizes your contribution and amplifies your impact.
  • Opportunities to grow your talent and drive your career, whether through promotion or lateral move.
  • A supportive, future-focused team environment.

About Us

We are Phiture, a company that builds trusted and loved brands connecting with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities while contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both a social and environmental point of view.


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