Regulatory Systems Strengthening Consultant
USP seeks consultants/vendors with expertise in one or more of the technical areas of interest below to be shortlisted for a candidate pool for potential future work in various countries throughout the Africa, Asia and Central Asia regions. Note that this is a general Call for Consultants to build a qualified applicant pool. This job posting does not guarantee employment. Consultants and firms who meet the outlined qualifications and skills listed below will be added to the USP Consultant Database for future potential engagement. Those selected to be added to the Consultant Database will be notified. This potential work would be completed under the guidance of USP’s Global Public Health (GPH) division. Applications may be made to one or more of the technical areas of interest, based on the consultant’s/vendor’s qualifications. Note that this is a remote role with possibility for travel. This is a global position and candidates worldwide are encouraged to apply. Note that this may be a remote position with possibility of travel.
Roles and Responsibilities
Support assessment activities of the Medicines Regulatory Authority (MRA) including conduct of GBT assessments, and the development of respective IDPs addressing system gaps of the different regulatory functions to attain ML3
Coordinate with the leadership of the MRA, donors and other partners to identify and deploy the necessary resources for IDP implementation
In collaboration with the MRA leadership, develop and implement recommendations for appropriate organizational structures/units reforms, or the delineation of new functions, roles and responsibilities, and procedures to support the MRA to adequately carry out its regulatory functions
Develop training programs ensuring their adequacy for transfer of knowledge and skills and for their institutionalization.
Provide technical support to MRAs on product marketing authorization, including vaccine registration, to reach WHO GBT Maturity Level 3.
Coordinate with the MRA and with ministry of health program departments to design and implement a post-marketing quality surveillance program that assures quality of vaccines.
Strengthen the MRA legal framework for vaccines manufacturing, supply, storage, and distribution.
Work closely with respective MRA staff and the national control lab to ensure the development of lot release testing capacity.
Support the GMP inspectorate of the MRA to strengthen its capacity for regulatory oversight of vaccine manufacturers.
Work with the MRA and other GPH technical experts to help the MRA implement aa ISO 9001:2015 quality management systems
Collaborate with other respective GPH staff to identify areas within the MRA that require specialized technical support, develop consultants’ scopes of work to address these areas and support the implementation of these consultancies ensuring their effectiveness.
Basic Qualifications
Education
Bachelor’s/ Master’s degree in pharmacy, pharmaceutical science, chemistry, or science related field of study required
Experience
At least six years of relevant experience in medicine regulation and quality assurance
Direct experience with and understanding and application of WHO Technical Report Series (TRS) guidelines including the implementation of global benchmarking tool and WHO prequalification procedures for medical products
Experience in project development and implementation with international organization
Work experience with government medicines regulatory agencies is required
Regulatory work experience with pharmaceutical industry is required
Experience in the regulation of biologics
Knowledge, Skills and Abilities (KSA’s)
Possess clear understanding of the pharmaceutical development process from pre-clinical development through life cycle management.
Possess clear understanding of the NRA functions, WHO-Prequalification, PIC/s membership processes.
Possess a deep understanding of the pharmaceutical regulatory environment in low income and middle-income countries in Africa and Central Asia.
Working understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices.
Should be a native French, Portuguese, or Russian speaker - Strong technical writing and oral communication skills in one of these languages.
Ability to communicate clearly in the English language.
Demonstrated progression in career with increasing responsibilities.
Ability to influence without direct authority.
Results driven with demonstrated successful outcomes.
Excellent training and facilitation skills.
Ability and desire to work with diverse employees and customers in a cooperative and friendly manner.
Ability to handle multiple priorities in a fast-paced environment.
Understanding about health programs HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH is an added advantage.
APPLICATION SUBMISSION REQUIREMENTS
Please send your CV to gph_procurement@usp.org by the 03/26/2024. When submitting your application, write “Call for RSS Consultant” in the email Subject Line. If you are applying for more than one Technical Area of Interest, please specify in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medicines and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.
