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Head of Regulatory Affairs(m/w/x)
Leading regulatory activities for specialty pharma products with a 10-member product team at a global Specialty Pharma company. 10+ years Regulatory Affairs experience and initial leadership required. 30 days holiday, individually customizable working models.
Requirements
- Degree in Natural Sciences, Pharmacy or Medicine
- At least 10 years of professional experience in Regulatory Affairs
- Initial leadership experience
- Strong understanding of multidisciplinary functions across the pharmaceutical product lifecycle
- Proven experience in development and leadership of regulatory strategies
- High competence in managing complex interfaces and engaging with stakeholders
- Cooperative and solution-oriented working approach
- Confident communication and negotiation skills in German and English
Tasks
- Lead regulatory activities for a product team of up to 10 members
- Ensure compliance with national and international regulations
- Develop and implement regulatory strategies aligned with company goals
- Take responsibility for all regulatory processes within the team
- Ensure timely execution and proactive risk management
- Provide regulatory expertise to internal functions and project teams
- Contribute to the optimization of regulatory processes and systems
- Act as the Regulatory Affairs representative in cross-functional initiatives
- Monitor and assess legislative and regulatory developments
- Evaluate the impact of regulations on the business
- Provide technical leadership and foster team development
- Manage external service providers for quality and compliance
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Flexible Working
- Individually customisable working models
More Vacation Days
- Compensatory time off
- 30 days of holiday
Additional Allowances
- Flexible benefits budget
- Subsidies for travel and meal costs
Healthcare & Fitness
- Fitness and health offers
Corporate Discounts
- Access to corporate benefits platform
Learning & Development
- Internal and external training courses
Team Events
- Company and team events
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Head of Regulatory Affairs(m/w/x)
Leading regulatory activities for specialty pharma products with a 10-member product team at a global Specialty Pharma company. 10+ years Regulatory Affairs experience and initial leadership required. 30 days holiday, individually customizable working models.
Requirements
- Degree in Natural Sciences, Pharmacy or Medicine
- At least 10 years of professional experience in Regulatory Affairs
- Initial leadership experience
- Strong understanding of multidisciplinary functions across the pharmaceutical product lifecycle
- Proven experience in development and leadership of regulatory strategies
- High competence in managing complex interfaces and engaging with stakeholders
- Cooperative and solution-oriented working approach
- Confident communication and negotiation skills in German and English
Tasks
- Lead regulatory activities for a product team of up to 10 members
- Ensure compliance with national and international regulations
- Develop and implement regulatory strategies aligned with company goals
- Take responsibility for all regulatory processes within the team
- Ensure timely execution and proactive risk management
- Provide regulatory expertise to internal functions and project teams
- Contribute to the optimization of regulatory processes and systems
- Act as the Regulatory Affairs representative in cross-functional initiatives
- Monitor and assess legislative and regulatory developments
- Evaluate the impact of regulations on the business
- Provide technical leadership and foster team development
- Manage external service providers for quality and compliance
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Flexible Working
- Individually customisable working models
More Vacation Days
- Compensatory time off
- 30 days of holiday
Additional Allowances
- Flexible benefits budget
- Subsidies for travel and meal costs
Healthcare & Fitness
- Fitness and health offers
Corporate Discounts
- Access to corporate benefits platform
Learning & Development
- Internal and external training courses
Team Events
- Company and team events
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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