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BOBoehringer Ingelheim

Regulatory Affairs Manager(m/w/x)

Basel
Full-timeWith Home OfficeExperienced

Executing drug regulatory affairs in Switzerland, focusing on timely product registrations and compliance. Swiss pharmaceutical legislation knowledge and fluent German/English required. Remote work opportunity, flexible hours.

Requirements

  • Professional experience in Regulatory Affairs
  • Experience in quality control or quality assurance in GxP environment (advantageous)
  • Knowledge of Swiss pharmaceutical legislation
  • Fluent German and English (written and spoken)
  • French and/or Italian language skills (plus)
  • Team player with collaborative mindset
  • Structured and organized working style
  • Strong communication skills

Tasks

  • Execute Drug Regulatory Affairs activities in Switzerland
  • Ensure timely product registrations
  • Maintain regulatory compliance and product positioning
  • Implement and adhere to corporate procedures
  • Contribute to local regulatory strategy
  • Support compliance monitoring at ROPU level
  • Manage local regulatory activities for timely approvals
  • Collaborate with Swiss Health Authorities and DRA teams
  • Represent the organization in regulatory meetings
  • Submit and maintain marketing authorizations
  • Handle variations, renewals, and safety reports
  • Provide regulatory input for local strategy
  • Support labeling and market access activities
  • Collaborate with quality, pharmacovigilance, and demand management
  • Support product lifecycle and launches
  • Maintain regulatory data in systems and databases
  • Oversee product complaint handling
  • Manage recall processes
  • Coordinate internal and external committees
  • Communicate with authorities as required
  • Prepare and review product quality reports

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent
  • FrenchBasic
  • ItalianBasic

Benefits

Other Benefits

  • 12-month fixed-term contract
  • Mutual support

Flexible Working

  • Flexible working hours
  • Remote work opportunity

Learning & Development

  • Training and development opportunities

Mental Health Support

  • Employee Assistance Programs

Mentorship & Coaching

  • Coaching services

Informal Culture

  • Collaborative work environment
  • Constructive collaboration
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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