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Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
Overseeing drug applications, renewals, and variations for life-saving biotech therapies. Minimum 5 years of international regulatory experience and a life sciences degree required. Global strategy team participation.
Requirements
- Degree in Biological, Medical Sciences, Pharmacy, or related field
- Postgraduate qualifications in Drug Regulatory Affairs as advantage
- Minimum 5 years of international regulatory experience
- Experience in pharmaceutical or biotech industry ideally
- Strong understanding of scientific principles and development
- Knowledge of GMP requirements
- Mandatory fluency in English
- Arabic, French, Spanish, or Russian as asset
- Ability to manage complex regulatory activities
- Ability to influence stakeholders and navigate environments
Tasks
- Define and drive regional regulatory strategies
- Align regional plans with global priorities
- Participate in Global Strategy Teams
- Contribute to complex scientific assessments
- Oversee drug applications, renewals, and variations
- Manage Health Authority interactions and PSURs
- Prepare high-quality regulatory documentation
- Respond to Health Authority inquiries
- Collaborate with local regulatory and internal partners
- Monitor international and regional regulatory changes
- Identify regulatory risks and provide expert guidance
- Support process improvements and training development
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- Arabic – Basic
- French – Basic
- Spanish – Basic
- Russian – Basic
Tools & Technologies
- GMP
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Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
Overseeing drug applications, renewals, and variations for life-saving biotech therapies. Minimum 5 years of international regulatory experience and a life sciences degree required. Global strategy team participation.
Requirements
- Degree in Biological, Medical Sciences, Pharmacy, or related field
- Postgraduate qualifications in Drug Regulatory Affairs as advantage
- Minimum 5 years of international regulatory experience
- Experience in pharmaceutical or biotech industry ideally
- Strong understanding of scientific principles and development
- Knowledge of GMP requirements
- Mandatory fluency in English
- Arabic, French, Spanish, or Russian as asset
- Ability to manage complex regulatory activities
- Ability to influence stakeholders and navigate environments
Tasks
- Define and drive regional regulatory strategies
- Align regional plans with global priorities
- Participate in Global Strategy Teams
- Contribute to complex scientific assessments
- Oversee drug applications, renewals, and variations
- Manage Health Authority interactions and PSURs
- Prepare high-quality regulatory documentation
- Respond to Health Authority inquiries
- Collaborate with local regulatory and internal partners
- Monitor international and regional regulatory changes
- Identify regulatory risks and provide expert guidance
- Support process improvements and training development
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- Arabic – Basic
- French – Basic
- Spanish – Basic
- Russian – Basic
Tools & Technologies
- GMP
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
CSL Behring AG (CH)
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein weltweit führendes Biotech-Unternehmen, das lebensrettende Therapien für Menschen mit schweren und seltenen Krankheiten entwickelt und vertreibt.
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