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CSCSL Behring AG (CH)

Regional Regulatory Lead - APAC, LATAM and Partner Business Regions(m/w/x)

Glattbrugg
Full-timeOn-siteSenior

Developing and implementing regional regulatory strategies for biotherapeutics in APAC and LATAM. Minimum 5 years international regulatory affairs experience required. Culture of curiosity and empathy.

Requirements

  • Degree in Biological Sciences, Medical Sciences, Pharmacy, or related field
  • Postgraduate qualifications or specialization in Drug Regulatory Affairs (advantageous)
  • Minimum 5 years regulatory affairs experience in international markets
  • Additional pharmaceutical or biotech industry experience (highly desirable)
  • Fluent English
  • Additional languages (e.g., Arabic, French, Spanish, Russian) (asset)
  • Strong understanding of pharmaceutical product development and regulatory requirements
  • Knowledge of GMP and GCP principles
  • Excellent communication, stakeholder management, and organizational skills
  • Ability to work effectively in global and cross-functional environment

Tasks

  • Lead strategic and operational regulatory activities
  • Act as regional regulatory lead for assigned products and countries
  • Develop and implement regional regulatory strategies
  • Identify efficient regulatory approval pathways
  • Contribute to Global Regulatory Affairs Strategy Team
  • Lead and oversee regulatory activities across portfolio
  • Identify and manage regulatory risks
  • Ensure high-quality regulatory submissions
  • Respond to Health Authority questions
  • Collaborate with internal stakeholders
  • Support timely approvals and regulatory compliance
  • Build relationships with regional Health Authorities
  • Stay informed on international regulatory legislation
  • Assess impact of evolving regulations
  • Provide regulatory risk assessments
  • Support continuous improvement initiatives

Work Experience

  • 5 years

Education

  • Vocational certificationOR
  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishFluent
  • ArabicBasic
  • FrenchBasic
  • SpanishBasic
  • RussianBasic

Benefits

Other Benefits

  • Inclusion and Belonging focus
  • Reasonable accommodation for disabilities

Informal Culture

  • Culture of curiosity and empathy
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring AG (CH) and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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