Dein persönlicher KI-Karriere-Agent
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Lockere Unternehmenskultur
- Diverse, open working environment
Flexibles Arbeiten
- Flexible working models
- Work-life balance
- Working time account
Workation & Sabbatical
- Work from another EU country (up to 2 months/year)
Mehr Urlaubstage
- 30 days of holiday
Sonstige Zulagen
- Flexible benefits budget
- Subsidies for meal costs
Betriebliche Altersvorsorge
- Company pension provision
Gesundheits- & Fitnessangebote
- Fitness and health offers
Öffi Tickets
- Subsidies for travel costs
Mitarbeiterrabatte
- Corporate benefits platform access
- Discounts at partner companies
Weiterbildungsangebote
- Internal training courses
- External training courses
Team Events & Ausflüge
- Company events
- Team events
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- CHEPLAPHARM Arzneimittel GmbHVollzeitmit HomeofficeSeniorGreifswald, Berlin, Binningen
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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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Lockere Unternehmenskultur
- Diverse, open working environment
Flexibles Arbeiten
- Flexible working models
- Work-life balance
- Working time account
Workation & Sabbatical
- Work from another EU country (up to 2 months/year)
Mehr Urlaubstage
- 30 days of holiday
Sonstige Zulagen
- Flexible benefits budget
- Subsidies for meal costs
Betriebliche Altersvorsorge
- Company pension provision
Gesundheits- & Fitnessangebote
- Fitness and health offers
Öffi Tickets
- Subsidies for travel costs
Mitarbeiterrabatte
- Corporate benefits platform access
- Discounts at partner companies
Weiterbildungsangebote
- Internal training courses
- External training courses
Team Events & Ausflüge
- Company events
- Team events
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
CHEPLAPHARM Arzneimittel GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globales und wachsendes Specialty Pharmaunternehmen mit einem außergewöhnlichen, nachhaltigen Geschäftsmodell.
Noch nicht perfekt?
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