European Regulatory Affairs Specialist

Há 5 dias


Lisboa, Lisboa, Portugal Phiture Tempo inteiro

About the Role

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

Key Responsibilities

  • Maintain and optimize existing SharePoint sites, with over 10 sites to manage.
  • Create new SharePoint sites as needed.
  • Develop and manage training programs for the PLM Portal, optimizing workflows for the EU platform to meet CHC needs.
  • Collaborate with PXL on weekly meetings to control, explain, and improve workflows, including ongoing and upcoming variations.
  • Create and maintain Veeva reports.
  • Manage Article 23 reports and establish a workflow for local-level notifications, involving Veeva reports, table cleaning, and affiliate contacts.
  • Oversee CMDh notifications, including upcoming workshops from the SRF extract to enable early communication during LRC approval.
  • Cease renewals preparation for MRP/DCP, integrating the renewal process into the EU platform.
  • Manage the ESPM portal at the EU level.
  • Monitor regulatory intelligence from the EMA website and PLM portal, attending necessary meetings regarding PLM portal implementation and shortages notification portal ESMP.

About You

  • Bachelor of Science or equivalent required, Master of Science preferred for this position.
  • Minimum 5 years of experience in the pharmaceutical industry, with demonstrated expertise in European regulatory affairs.
  • Strong understanding of regulatory procedures and end-to-end processes.
  • Able to think strategically and translate business and technical objectives into roadmaps, projects, and data strategies.
  • Excellent interpersonal skills, negotiation skills, and verbal and written communication skills.
  • Ability to adapt quickly to changing priorities and meet tight deadlines while maintaining high quality standards.
  • Proactive problem-solving and analysis skills, with experience in multitasking and working in a global team environment.
  • Familiarity with organizational and intercultural sensitivities, with the ability to apply this knowledge to day-to-day practices.
  • Fluent in spoken and written English.

Compensation and Benefits

This exciting opportunity comes with a competitive salary of approximately €80,000 per year, plus a comprehensive benefits package that includes professional development opportunities, a supportive work environment, and a commitment to diversity and inclusion.


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