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Regulatory Affairs Manager(m/w/x)
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
- German – Business Fluent
- English – Business Fluent
- French – Basic
- Italian – Basic
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
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Regulatory Affairs Manager(m/w/x)
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
- German – Business Fluent
- English – Business Fluent
- French – Basic
- Italian – Basic
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
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Boehringer Ingelheim
Industry
Pharmaceuticals
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
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