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CSL Behring AG (CH)
15d ago

Regional Regulatory Lead – APAC, LATAM & Partner Business(m/w/x)

Glattbrugg
Full-timeOn-siteSenior

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.

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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

Bachelor's degree
OR
Master's degree

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

GMP

Languages

EnglishBusiness Fluent

ArabicBasic

FrenchBasic

SpanishBasic

RussianBasic

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