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ERGOMED

Senior Specialist, Regulatory Intelligence and Analytics

ERGOMED

. Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables .

Posted 5/2/2026full-timeRemote • 🇵🇱 PolandSeniorWebsite

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
  • Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
  • Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures.
  • Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
  • Ensure compliance with company procedures, processes, training records, systems and any other tools
  • Provide training, coaching and mentoring to junior members of staff.

Requirements

What you’ll need
  • Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Strong previous experience within pharmaceutical or CRO industry or Regulatory body
  • Previous Project Management experience is desirable
  • Knowledge of Pharmacovigilance/Regulatory field
  • Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency.
  • Fluent Proficiency in English, both written and verbal.
  • Additional languages are desirable.
  • Strong organization skills and detailed orientated approach to work

Benefits

Comp & perks
  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
Project ManagementRegulatory IntelligencePharmacovigilanceICH GCPGVPRegulatory ComplianceQuality ControlLegislative RequirementsDatabase MaintenanceRisk Management
Soft Skills
LeadershipProblem SolvingCoachingMentoringCommunicationOrganizationDetail Orientation