The Global Fund to Fight AIDS, Tuberculosis and Malaria
Specialist, QA Regulatory Harmonization, Regional Production & Capacity Building(m/w/x)
Full-timeOn-siteSenior
Genf
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GLGlobal Antibiotic R&D Partnership (GARDP)
Regulatory Affairs Manager(m/w/x)
Genf
Full-timeOn-siteSenior
Nejo AI Summary
Global regulatory strategy development and dossier submission for antibiotic treatments. 8+ years RA experience, including international submissions and WHO PQ pathways, required. 4-week workation option.
Requirements
- Advanced degree in Pharmacy, Life Sciences, or related scientific discipline
- Minimum 8 years relevant Regulatory Affairs experience, including at least 5 years senior officer level or equivalent
- Demonstrated experience managing international regulatory submissions (Africa, Asia, others) and WHO PQ pathways
- Experience working with or within Marketing Authorization Holders (MAHs)
- Strong knowledge of global regulatory frameworks, lifecycle management, and inspection processes
- Experience supporting complex, multi-partner or multi-pathway projects is highly desirable
- Experience working in public and private sector environments is highly desirable
- Strategic thinking and strong operational execution
- Excellent project management and prioritization skills
- Strong analytical and problem-solving capabilities
- Effective stakeholder management and cross-functional communication
- High attention to detail and regulatory compliance orientation
- Integrity: Leads by example with strong ethics and fairness
- Communication: Communicates with clarity and empathy across levels and functions
- Assertiveness: Advocates for team and organization with confidence and respect
- Agility: Responds rapidly to change while maintaining focus and supporting others
- Integrity: Act with transparency and ethics
- Inclusivity: Promote equal opportunity and diverse participation
- Teamwork: Champion collaboration
- Courage: Embrace innovation
- Excellence: Pursue high standards
- People-Centered: Value human dignity and stakeholder engagement
Tasks
- Lead regulatory dossier preparation, coordination, and submission with MAHs
- Develop and implement harmonized regulatory strategies with MAHs
- Provide strategic oversight of multiple concurrent product registrations
- Monitor evolving global and local regulatory requirements
- Oversee post-approval lifecycle management activities with MAHs
- Support regulatory inspection and audit readiness
- Provide regulatory oversight for the Managed Access Program
- Contribute to departmental efficiency through process optimization
- Act as a key regulatory interface with internal and external partners
- Represent GARDP in interactions with regulatory authorities and partners
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Global Antibiotic R&D Partnership (GARDP) 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.
Not a perfect match?
- Coty Inc.
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Full-timeOn-siteSeniorGenf - The Global Fund to Fight AIDS, Tuberculosis and Malaria
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Full-timeOn-siteSeniorGenf - The Global Fund to Fight AIDS, Tuberculosis and Malaria
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Full-timeOn-siteManagementGenf
GLGlobal Antibiotic R&D Partnership (GARDP)
Regulatory Affairs Manager(m/w/x)
Genf
Full-timeOn-siteSenior
Nejo AI Summary
Global regulatory strategy development and dossier submission for antibiotic treatments. 8+ years RA experience, including international submissions and WHO PQ pathways, required. 4-week workation option.
Requirements
- Advanced degree in Pharmacy, Life Sciences, or related scientific discipline
- Minimum 8 years relevant Regulatory Affairs experience, including at least 5 years senior officer level or equivalent
- Demonstrated experience managing international regulatory submissions (Africa, Asia, others) and WHO PQ pathways
- Experience working with or within Marketing Authorization Holders (MAHs)
- Strong knowledge of global regulatory frameworks, lifecycle management, and inspection processes
- Experience supporting complex, multi-partner or multi-pathway projects is highly desirable
- Experience working in public and private sector environments is highly desirable
- Strategic thinking and strong operational execution
- Excellent project management and prioritization skills
- Strong analytical and problem-solving capabilities
- Effective stakeholder management and cross-functional communication
- High attention to detail and regulatory compliance orientation
- Integrity: Leads by example with strong ethics and fairness
- Communication: Communicates with clarity and empathy across levels and functions
- Assertiveness: Advocates for team and organization with confidence and respect
- Agility: Responds rapidly to change while maintaining focus and supporting others
- Integrity: Act with transparency and ethics
- Inclusivity: Promote equal opportunity and diverse participation
- Teamwork: Champion collaboration
- Courage: Embrace innovation
- Excellence: Pursue high standards
- People-Centered: Value human dignity and stakeholder engagement
Tasks
- Lead regulatory dossier preparation, coordination, and submission with MAHs
- Develop and implement harmonized regulatory strategies with MAHs
- Provide strategic oversight of multiple concurrent product registrations
- Monitor evolving global and local regulatory requirements
- Oversee post-approval lifecycle management activities with MAHs
- Support regulatory inspection and audit readiness
- Provide regulatory oversight for the Managed Access Program
- Contribute to departmental efficiency through process optimization
- Act as a key regulatory interface with internal and external partners
- Represent GARDP in interactions with regulatory authorities and partners
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Global Antibiotic R&D Partnership (GARDP) 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.
About the Company
Global Antibiotic R&D Partnership (GARDP)
Industry
Healthcare
Description
GARDP Foundation is a not-for-profit global health organization focused on combating drug-resistant infections by developing and making accessible antibiotic treatments.
Not a perfect match?
- The Global Fund to Fight AIDS, Tuberculosis and Malaria
Specialist, QA Regulatory Harmonization, Regional Production & Capacity Building(m/w/x)
Full-timeOn-siteSeniorGenf - Coty Inc.
Manager Regulatory Affairs(m/w/x)
Full-timeOn-siteSeniorGenf - The Global Fund to Fight AIDS, Tuberculosis and Malaria
Lead, TRP & GAC Secretariat - GL D(m/w/x)
Full-timeOn-siteSeniorGenf - The Global Fund to Fight AIDS, Tuberculosis and Malaria
Specialist, QA Policy & Governance - GL D(m/w/x)
Full-timeOn-siteSeniorGenf - The Global Fund to Fight AIDS, Tuberculosis and Malaria
Head of Malaria - GL F(m/w/x)
Full-timeOn-siteManagementGenf