Regulatory Systems and GMP Expert (per regional team) – Austria

Aninver; Osterreich; Hybrid; PEN 349,000 - 505,000; Full time

Job summary

Aninver Development Partners seeks a Regulatory Systems and GMP Expert to join its regional team for a UNIDO-funded health consultancy in Austria. The expert will assess medicines regulatory systems, GMP compliance, and regulatory harmonization efforts to bolster local production and quality infrastructure.

The assignment involves evaluating regulatory maturity, market-entry pathways, and dossier readiness, with contribution to milestone reports and stakeholder workshops.

Qualifications

• Experience with WHO GMP, EU GMP, or equivalent GMP systems.
• Experience with medicines regulatory systems and regulatory harmonization in Africa.
• Languages: proficiency per regional team language requirements.

Responsibilities

• Lead assessment of regional regulatory systems, quality infrastructure, and compliance mechanisms.
• Evaluate enterprise production systems against WHO GMP, EU GMP, or equivalent standards.
• Analyze registration procedures, marketing authorization pathways, and regulatory bottlenecks.
• Support WHO Global Benchmarking Tool maturity strengthening activities across participating countries.
• Collaborate with multidisciplinary team members to integrate regulatory findings into value chain diagnostics.
• Contribute inputs to milestone reports, technical deliverables, and stakeholder engagement workshops.

Skills

GMP expertise

Regulatory systems

Regulatory harmonization

WHO GMP

EU GMP

Stakeholder engagement

Education

Relevant professional qualifications

Job description

Aninver Development Partners SL (www.aninver.com) is looking for a Regulatory Systems and GMP Expert (per regional team) for a health consultancy assignment financed by UNIDO in Austria.

Aninver Development Partners SL is preparing a technical proposal for an upcoming consulting assignment in the health sector, supported by UNIDO. The initiative aims to enhance trade competitiveness, market access, and industrial development within key regional economic communities in Africa by strengthening pharmaceutical manufacturing value chains, upgrading compliance, and fostering regional integration.

We are currently seeking a qualified Regulatory Systems and GMP Expert to join our regional team for this assignment. The expert will play a pivotal role in assessing medicines regulatory systems, evaluating good manufacturing practices, and supporting regulatory harmonization frameworks to bolster local production and quality infrastructure.

Aninver is preparing a proposal for this assignment. The selected expert will be part of the proposed team; the engagement is conditional on the contract being awarded to Aninver. The full Terms of Reference for the position are shared with shortlisted candidates.

Objectives of the assignment

• Assess regional medicines regulatory systems and institutional readiness across targeted member states.
• Evaluate compliance with international standards, specifically WHO GMP, EU GMP, or equivalent systems.
• Contribute to WHO Global Benchmarking Tool maturity strengthening and regional regulatory harmonization efforts.
• Identify systemic regulatory constraints affecting pharmaceutical manufacturing competitiveness and market entry.

Scope of work

• Validate priority product segments and map registration and market-entry pathways.
• Evaluate regulatory maturity and institutional readiness across national and regional bodies.
• Assess quality control and reference laboratory readiness, as well as traceability and market surveillance architecture.
• Examine enterprise-level production systems, manufacturing capabilities, and dossier readiness.
• Contribute to integrated constraint analyses, prioritization frameworks, and intervention roadmaps.
• Participate in stakeholder validation workshops and technical consultations.

Your role as Regulatory Systems and GMP Expert (per regional team)

• Lead the assessment of regional regulatory systems, quality infrastructure, and compliance mechanisms.
• Evaluate enterprise production systems against WHO GMP, EU GMP, or equivalent standards.
• Analyze registration procedures, marketing authorization pathways, and regulatory bottlenecks.
• Support WHO Global Benchmarking Tool maturity strengthening activities across participating countries.
• Collaborate with multidisciplinary team members to integrate regulatory findings into overarching value chain diagnostics.
• Contribute inputs to milestone reports, technical deliverables, and stakeholder engagement workshops.

Requirements

• Education: Relevant professional qualifications
• Demonstrated experience in WHO GMP, EU GMP, or equivalent GMP systems, and experience with medicines regulatory systems, WHO Global Benchmarking Tool maturity strengthening, and regulatory harmonization in Africa
• Languages: Proficiency required per regional team language requirements

Desirable

• Prior experience working on UNIDO or international donor-funded industrial development programs.
• Experience in conducting institutional assessments and supporting pharmaceutical sector upgrading.

An experienced regulatory affairs and GMP professional with deep knowledge of African pharmaceutical frameworks, international quality standards, and regulatory harmonization initiatives.

Assignment details

• Location: Austria
• Financed by: UNIDO
• Sector: Health
• Positions: 2
• Expected input: null
• Contract: individual consultancy (conditional on award)

About Aninver Development Partners

Aninver is an international development consulting firm headquartered in Spain. It supports governments, development banks, UN agencies and bilateral donors with feasibility studies, technical assistance, evaluations and capacity building across Africa, Latin America, the Caribbean, Europe, the Caucasus, Central Asia and Asia-Pacific, working with a network of international and national experts.

Why apply

• Join a multidisciplinary team on a UNIDO-financed project in Austria.
• Individual consultancy: flexible, output-based engagement with an experienced proposal team.
• Your CV stays in Aninver's expert network for future assignments that match your profile.

Frequently asked questions

Is the position confirmed? The engagement depends on the contract being awarded to Aninver. Shortlisted experts are included in the proposal with their consent.

Can I apply if I am not based in the country? Yes, unless the requirements say otherwise; relevant regional experience is an asset.

What happens with my CV? It is used to assess your fit for this and future positions and is not shared with third parties without your consent.