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Regional Regulatory Lead - APAC, LATAM and Partner Business Regions(m/w/x)
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
- English – Fluent
- Arabic – Basic
- French – Basic
- Spanish – Basic
- Russian – Basic
Benefits
Other Benefits
- Inclusion and Belonging focus
- Reasonable accommodation for disabilities
Informal Culture
- Culture of curiosity and empathy
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Regional Regulatory Lead - APAC, LATAM and Partner Business Regions(m/w/x)
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
- English – Fluent
- Arabic – Basic
- French – Basic
- Spanish – Basic
- Russian – Basic
Benefits
Other Benefits
- Inclusion and Belonging focus
- Reasonable accommodation for disabilities
Informal Culture
- Culture of curiosity and empathy
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.
Not a perfect match?
- CSL Behring AG (CH)
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