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Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
Description
You will shape the regulatory landscape for immunoglobulin products across APAC and LATAM, balancing complex scientific assessments with strategic planning to ensure seamless market approvals.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
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
Tools & Technologies
Languages
English – Business Fluent
Arabic – Basic
French – Basic
Spanish – Basic
Russian – Basic
- CSL Behring L.L.C.Full-timeOn-siteSeniorGlattbrugg
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Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)
The AI Job Search Engine
Description
You will shape the regulatory landscape for immunoglobulin products across APAC and LATAM, balancing complex scientific assessments with strategic planning to ensure seamless market approvals.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
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
Tools & Technologies
Languages
English – Business Fluent
Arabic – Basic
French – Basic
Spanish – Basic
Russian – Basic
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.
- CSL Behring L.L.C.
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Full-timeOn-siteSeniorGlattbrugg - CSL Behring
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