Regulatory Compliance Specialist

1 day ago


Athens, Attica, Greece beBeeRegulatoryAffairs Full time
Regulatory Affairs Supervisor Position">

At a leading pharmaceutical manufacturer, we seek a skilled Regulatory Affairs (Pre-Approval) Supervisor to oversee regulatory projects and ensure compliance with regulations.

  • Strategic understanding of regulatory requirements and documentation processes
  • Lead regulatory team members in assigned projects
  • Develop and manage regulatory documentation for product applications within set timelines
  • Coach and review deliverables of Regulatory Affairs Officers and Associates
  • Maintain effective communication with external regulatory authorities as needed
  • Review and implement policies and procedures to ensure compliance
  • Collaborate with various departments to collect necessary information and documentation for Pharmaceutical Dossier submissions
  • Support internal activities to ensure regulatory compliance of registered products
  • Compile and track scientific responses to regulatory deficiencies
Required Skills & Qualifications
  • Bachelor's Degree in Pharmacy, Biology or relevant field
  • 5+ years of experience in Regulatory Affairs within a pharmaceutical organization
  • Fluency in English and proficiency in MS Office
  • Strong organizational skills, ability to multitask and meet deadlines
  • Effective communication and relationship management
  • Knowledge of EU regulatory guidelines
  • Ability to work under pressure and maintain resilience
Benefits

This role offers competitive compensation, continuous training opportunities, career development support and a professional working environment.



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