Consultant for Medicine Dossier Assessors and GMP/GSDP Auditors

Job Posting Organization:
UNICEF, established in 1946, operates in over 190 countries and territories with a mission to save children's lives, defend their rights, and help them fulfill their potential. The organization is committed to promoting the rights of every child and offers diverse opportunities for professional and personal development. UNICEF employs a passionate workforce dedicated to serving children and communities globally, and it emphasizes a culture of inclusivity and growth.

Job Overview:
The position involves establishing a roster of pre-qualified external consultants to enhance UNICEF's in-house capacity for technical assessments of medicinal product dossiers and audits against Good Manufacturing Practices (GMP) and Good Storage and Distribution Practices (GSDP). The consultants will support UNICEF's localization agenda for medicinal products and expanded supply operations in low- and middle-income countries (LMICs). Quality assurance is central to UNICEF's mandate, ensuring timely access to safe and quality-assured medicines. The consultants will work under the supervision of designated UNICEF staff and will be engaged on an individual consultancy contract basis, with work locations being home-based and assignments that may require travel.

Duties and Responsibilities:
The consultants will be responsible for conducting technical assessments of medicinal product applications, assessing administrative sections, Chemistry, Manufacturing and Controls (API and FPP), and safety/efficacy data. They will provide written assessment reports with clear queries, conclusions, and recommendations, and contribute to capacity-building when required. For GMP/GSDP auditors, responsibilities include planning and conducting GMP audits of finished medicinal products and sterile API powder manufacturers, conducting GSDP audits for warehouses and distributors, preparing audit reports, classifying observations, and following up on corrective actions. The consultants will also participate in debriefings and post-audit reviews, ensuring compliance with WHO and Codex Alimentarius standards.

Required Qualifications:
Candidates must possess an advanced university degree (Master’s or higher) in Pharmacy, Pharmaceutical Sciences/Regulation, or a related field with specialization in Chemistry, Manufacturing and Controls (CMC). They should have at least 8 years of progressive experience relevant to pharmaceutical regulation, including hands-on product assessment at the national level. Strong knowledge of pharmaceutical markets, regulatory science, and procurement interfaces is essential, along with excellent technical writing skills in English. Additional UN languages are considered an asset.

Educational Background:
The educational background required for this position includes an advanced university degree (Master’s or higher) in a relevant field such as Pharmacy, Pharmaceutical Sciences, or Regulation, with a specialization in Chemistry, Manufacturing, and Controls (CMC). This advanced education is crucial for understanding the complexities of medicinal product assessments and regulatory compliance.

Experience:
Candidates should have a minimum of 8 years of proven regulatory experience in pharmaceutical regulation, including experience in conducting audits and assessments of medicinal products. Experience at the national, regional, or global level is advantageous, particularly in the context of GMP and GSDP audits. Familiarity with WHO, PIC/S, and other stringent regulatory requirements is also required.

Languages:
Fluency in English is mandatory, with strong technical writing skills. Proficiency in additional UN languages is considered an asset, enhancing communication and reporting capabilities in a diverse work environment.

Additional Notes:
The consultancy contracts will have a duration of up to three years from selection, with the possibility of renewal based on performance and organizational needs. The work will be home-based, with assignments that may require travel, subject to UNICEF travel rules. Remuneration will be commensurate with expertise and experience, and interested experts should submit their daily rate expectations. UNICEF is committed to diversity and inclusion, encouraging applications from all qualified individuals, and offers a range of benefits including paid parental leave and reasonable accommodations for persons with disabilities.