Job Purpose:
- The Chanjo Hub Project is a groundbreaking initiative focused
on the development and manufacturing of a candidate malaria vaccine using
egg production in Ghana, coupled with innovative mRNA technology in Kenya.
With the aim of combating malaria, our project brings together a diverse
team of experts and collaborators to advance research and development in
the field of malaria immunisation.
Description:
Reports To: Principal Investigator (PhD – Postdocs and Research Fellows)
Directly Supervises: Field workers, interns etc
Indirectly Supervises: None.
budget and resource responsibility: Develop project budget
Job Dimensions:
- We are seeking a highly motivated and detail-oriented
Assistant Research Officer (ARO) to join our team and contribute to the
regulatory strengthening aspects of the Chanjo Hub Project. The successful
candidate will play a crucial role in ensuring compliance with regulatory
requirements for the manufacturing of the malaria vaccine by egg
production in Ghana and by mRNA in Kenya. This role will involve working
with internal teams in both countries to ensure regulatory compliance,
developing institutional development plans for regulatory strengthening,
collaborating with National Regulatory Authorities (NRAs) to facilitate
process evaluations, and evaluating the readiness or strengthening needs
of National Regulatory Authorities in alignment with the WHO NRA maturity
levels.
Key Responsibilities:
Institutional Development Plans:
- Work with internal teams in Kenya and Ghana to develop vaccine
regulatory institutional development plans.
- Assist in the implementation of strategies to enhance
regulatory capabilities within the organisations.
Regulatory Compliance Oversight:
- Collaborate with internal teams in Kenya and Ghana to ensure
compliance with local and international regulatory requirements for mRNA
vaccine production and egg production, respectively.
- Provide guidance and support to internal teams to navigate
regulatory processes effectively.
Project Coordination:
- Liaise with internal teams to integrate regulatory
considerations into project timelines.
- Coordinate with external partners and vendors (USP, GIZ, PPB
and Ghana FDA) involved in the regulatory process.
- Create reports and update grant reports in liaison with CHANJO
hub program manager.
National Regulatory Authority Collaboration:
- Work with USP to identify and document NRA gaps facilitating
and providing input in meetings and workshops.
- Through USP, facilitate National Regulatory Authorities in
Kenya and Ghana’s understanding of the vaccine production and egg
production processes.
- Contribute to USP plans to evaluate National Regulatory
Authority readiness or strengthening needs, in alignment with WHO maturity
levels.
Documentation and Reporting:
- Maintain accurate and up-to-date documentation of all
regulatory activities of Chanjo hub.
- Prepare and submit regular reports on regulatory progress and
milestones.
- Create and maintain records of meeting minutes, workshop and
audit reports.
Qualifications:
- Minimum Bachelor’s degree in a relevant scientific field
(biology, biochemistry, pharmaceutical sciences, etc.).
- Minimum two(2) years prior experience in regulatory affairs,
preferably in the pharmaceutical or vaccine development industry.
Desirable Criteria:
- Knowledge of mRNA and egg-based vaccine production processes
and regulatory requirements.
- Familiarity with WHO maturity levels for regulatory systems.
- Strong organisational and project management skills.
- Excellent communication and interpersonal skills
Competencies:
- Demonstrate high levels of integrity and confidentiality
- Excellent interpersonal, written, presentation and
communication skills
- Basic analytical, problem solving and critical thinking
skills;
- Team working and ability to work in diverse teams
- Flexibility, adaptability, multi-tasking and attention to
detail
How To Apply
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