Regulatory Affairs Manager (CH or Spain or UK or South Africa)

About the job

GARDP Foundation is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them.

About the role

The Regulatory Affairs Manager serves as a strategic and operational partner within the Regulatory Affairs (RA) function to ensure leadership continuity, operational stability, and sustained oversight of key regulatory activities.

This role is critical in supporting GARDP’s expanding portfolio of global registration projects and managing increasing regulatory complexity across multiple international territories (eg. Africa, Asia and others), including engagement with WHO Prequalification (WHO PQ) pathways and alternative regulatory mechanisms.

Reporting to the Head of Regulatory Affairs, the Regulatory Affairs Manager ensures timely and compliant regulatory submissions with the Market Authorization holders (MAH), contributes to strategic regulatory planning, and supports inspection readiness, lifecycle management, and Managed Access Program compliance. The role directly contributes to ensuring sustainable global access to essential antibiotic treatments

Tasks and Responsibilities

·       Lead and oversee the preparation, coordination, and submission of regulatory dossiers with the MAH across assigned international markets, ensuring timeliness, completeness, and compliance.

·       Develop and implement harmonized regulatory strategies in collaboration with the MAHs, ensuring efficient and aligned submission approaches across international territories and WHO PQ pathways.

·       Provide strategic oversight of multiple concurrent product registrations, including complex multi-country submissions and alternative regulatory pathways.

·       Monitor evolving global and local regulatory requirements, proactively adapting submission strategies to ensure continued compliance and alignment.

·       Oversee post-approval lifecycle management activities, including variations, renewals, safety updates, and regulatory maintenance activities in collaboration with MAHs.

·       Support regulatory inspection and audit readiness by ensuring documentation accuracy, completeness, and timely response to authority inquiries and commitments.

·       Provide regulatory oversight and guidance for the Managed Access Program, ensuring compliance with applicable frameworks and country-specific requirements.

·       Contribute to departmental efficiency through process optimization and continuous improvement initiatives within the Regulatory Affairs function.

·       Act as a key regulatory interface with internal cross-functional teams and external regulatory partners to ensure alignment and delivery of strategic objectives.

Main Interactions

Internal:

·       Clinical, Pharmaceutical Development, Quality, Supply Chain and Access teams

·       cross-functional project teams

External:

·       Marketing Authorization Holders (MAHs)

·       Regulatory authorities in countries

·       External regulatory consultants and partners

Others

·       Travel requirements : 20% if required

·       External representation: May represent GARDP in interactions with regulatory authorities, MAHs, and external partners as delegated by the Head of Regulatory Affairs.

Qualification and Competencies

Qualifications

•                     Advanced degree in Pharmacy, Life Sciences, or a related scientific discipline.

•                     Minimum 8 years of relevant Regulatory Affairs experience, including at least 5 years at senior officer level or equivalent responsibility.

•                     Demonstrated experience managing international regulatory submissions (eg. Africa, Asia and 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.

Core Competencies

•                     Strategic thinking combined with 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

GARDP Leadership Competencies

·       Integrity : Leads by example with strong ethics and fairness in decision-making.

·       Communication : Communicates with clarity and empathy across levels and functions.

·       Assertiveness : Advocates for the team and organization with confidence and respect.

·       Agility : Responds rapidly to change while maintaining focus and supporting others.

Candidates must reflect and promote the organization`s core values and behaviours:

·       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.