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Senior Portfolio Owner Regulatory Affairs(m/w/x)
Global regulatory strategy development and submission oversight for established pharmaceutical brands. 10+ years of leadership experience managing large RA organizations required. Work from another EU country up to 2 months/year.
Requirements
- Master’s degree in scientific or pharmaceutical discipline
- More than 10 years of professional experience in Regulatory Affairs
- More than 10 years of proven leadership experience
- Managing large, cross-functional Regulatory Affairs organizations
- Leading global and international teams
- Strong conflict resolution ability
- Effective collaboration across complex stakeholder environments
- Excellent indirect leadership skills
- Excellent communication skills
- Excellent influencing skills
- Interaction with external stakeholders and regulatory partners
Tasks
- Ensure end-to-end regulatory and product activities
- Develop global regulatory strategy
- Oversee submission activities and agency interactions
- Ensure compliance with national and international regulations
- Provide leadership to the product team
- Prioritize tasks and allocate resources
- Manage budget and develop team capabilities
- Foster cross-functional alignment with internal departments
- Act as central escalation point for regulatory and product topics
- Assess and manage complex regulatory and business risks
- Develop sustainable solutions with long-term impact
- Lead external service providers and outsourcing activities
- Ensure quality and compliance in external partnerships
- Evaluate regulatory developments and market trends
- Improve processes and governance structures
- Support long-term organizational effectiveness
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Informal Culture
- Diverse, open working environment
Flexible Working
- Flexible working models
- Work-life balance
- Working time account
Workation & Sabbatical
- Work from another EU country (up to 2 months/year)
More Vacation Days
- 30 days of holiday
Additional Allowances
- Flexible benefits budget
- Subsidies for meal costs
Retirement Plans
- Company pension provision
Healthcare & Fitness
- Fitness and health offers
Public Transport Subsidies
- Subsidies for travel costs
Corporate Discounts
- Corporate benefits platform access
- Discounts at partner companies
Learning & Development
- Internal training courses
- External training courses
Team Events
- Company events
- Team events
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Senior Portfolio Owner Regulatory Affairs(m/w/x)
Global regulatory strategy development and submission oversight for established pharmaceutical brands. 10+ years of leadership experience managing large RA organizations required. Work from another EU country up to 2 months/year.
Requirements
- Master’s degree in scientific or pharmaceutical discipline
- More than 10 years of professional experience in Regulatory Affairs
- More than 10 years of proven leadership experience
- Managing large, cross-functional Regulatory Affairs organizations
- Leading global and international teams
- Strong conflict resolution ability
- Effective collaboration across complex stakeholder environments
- Excellent indirect leadership skills
- Excellent communication skills
- Excellent influencing skills
- Interaction with external stakeholders and regulatory partners
Tasks
- Ensure end-to-end regulatory and product activities
- Develop global regulatory strategy
- Oversee submission activities and agency interactions
- Ensure compliance with national and international regulations
- Provide leadership to the product team
- Prioritize tasks and allocate resources
- Manage budget and develop team capabilities
- Foster cross-functional alignment with internal departments
- Act as central escalation point for regulatory and product topics
- Assess and manage complex regulatory and business risks
- Develop sustainable solutions with long-term impact
- Lead external service providers and outsourcing activities
- Ensure quality and compliance in external partnerships
- Evaluate regulatory developments and market trends
- Improve processes and governance structures
- Support long-term organizational effectiveness
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Informal Culture
- Diverse, open working environment
Flexible Working
- Flexible working models
- Work-life balance
- Working time account
Workation & Sabbatical
- Work from another EU country (up to 2 months/year)
More Vacation Days
- 30 days of holiday
Additional Allowances
- Flexible benefits budget
- Subsidies for meal costs
Retirement Plans
- Company pension provision
Healthcare & Fitness
- Fitness and health offers
Public Transport Subsidies
- Subsidies for travel costs
Corporate Discounts
- Corporate benefits platform access
- Discounts at partner companies
Learning & Development
- Internal training courses
- External training courses
Team Events
- Company events
- Team events
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
CHEPLAPHARM Arzneimittel GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globales und wachsendes Specialty Pharmaunternehmen mit einem außergewöhnlichen, nachhaltigen Geschäftsmodell.
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