Ifakara Health Institute (IHI) is a leading research organization in Africa with a strong track record in developing, testing and validating innovations for health. Driven by a core strategic mandate for research, training and services, the Institute’s work now spans a wide spectrum, covering biomedical and ecological sciences, intervention studies, health-systems research, service delivery and policy translation.
Position Summary
Ifakara Health Institute is seeking a qualified Pharmacist who will be stationed at Bagamoyo Office under SINCEP – Africa Project, reporting to the Project Leader. Pharmacist will lead regulatory and ethics stakeholder engagement, advises investigators on approval pathways; facilitates pre-submission engagement; supports interaction with submission systems and oversight bodies, follows up outstanding reviews and decisions, troubleshoots approval delays; and advises on approval conditions and post-approval obligations through study completion. The Pharmacist wil support investigators and coordinators on regulatory and ethics pathways and engages relevant bodies, including the IHI Research Ethics Committee, NIMR/NatHREC, TMDA, COSTECH, AVAREF, foreign regulators and ethics committees, sponsors, CROs, funders and partner institutions, as applicable.
Responsibility:
Operates BCTF’s regulatory and ethics stakeholder-engagement, pathway-advisory, approval-follow-up and regulatory-intelligence functions.
Establishes and maintains effective engagement with institutional, national, regional and international regulatory and ethics stakeholders.
Provides investigators with specialist regulatory and ethics advice from concept development through study completion.
Develops and maintains Regulatory and Ethics Pathway Advisories.
Facilitates pre-submission engagement with authorities, committees, permit bodies and regional review mechanisms.
Supports navigation of submission portals and resolution of significant procedural, access and validation barriers.
Actively follows up outstanding acknowledgements, reviews, queries, decisions, approvals, permits and closure outcomes.
Proactively identifies and troubleshoots internal and external barriers that may delay approval or continued authorization.
Coordinates access to appropriate scientific, clinical, ethical, legal, financial and technical expertise.
Maintains portfolio-level visibility of significant approval barriers, recurring deficiencies and unresolved conditions.
Provides early warning and direct advice to the Head of BCTF on regulatory and ethics risks and their operational implications.
Collaborates laterally with the QSPC Coordinator where regulatory requirements must be translated into procedures, training, records, QC or inspection readiness.
Maintains records of advice, stakeholder engagement, pathway decisions, follow-up and escalation.
Reviews each proposed study’s regulatory and ethics pathway, review sequence, indicative timelines and approval dependencies.
Identifies expected approvals, clearances, permits, insurance arrangements and product, specimen, data and biosafety permissions.
Advises whether pre-submission engagement is required or advantageous.
Reviews submission packages strategically for major gaps, inconsistencies and pathway risks.
Confirms that substantive issues have been referred to appropriate accountable experts.
Advises on institutional endorsements, authorised signatures and supporting documentation.
Supports interpretation and resolution of significant validation issues and review questions.
Follows up significant submission and approval delays and facilitates corrective action.
Advises the Head of BCTF on approval conditions that must be completed before activation.
Reassesses the pathway following material protocol, product, population, site, country, sponsor or regulatory changes.
Advises on significant post-approval, renewal and study-closure requirements.
Ensures that applicable trial-specific pharmaceutical activities are assigned to appropriately qualified personnel and documented in the study-specific delegation log, including o Investigation-product or medicine preparation. o Dispensing and accountability. o Rescue-medicine or antidote management; and o Pharmaceutical support during emergency treatment.
Skill :
Investigational-product or medicine preparation skills.
Qualification Required:
Postgraduate degree or Bachelor degree in pharmacy, public health, clinical epidemiology, epidemiology, clinical research, clinical trials, clinical pharmacology or a demonstrably related field.
Experience :
More than 3 years clinical research experience, with a strong understanding of drugs /vaccine clinical trials in humans.
Current GCP training substantial clinical trials experience.
Experience with clinical-research regulatory and ethics approval pathways.
Demonstrated experience with Tanzanian regulatory, ethics and research-permit requirements.
Experience using and troubleshooting electronic regulatory, ethics and permit submission portals.
Clear written and verbal communication (English & Swahili).
Disclaimer! Ifakara Health Institute does not charge any fee at any stage of the recruitment process. Please disregard written or oral request for a Job offer or an interview that you believe is or might be fraudulent or suspicious.
Job Opening date :03-Aug-2026
Job closing date :14-Aug-2026
How to Apply: Job type Full-time Job, To submit your application, please follow the link provided below. CLICK HERE TO APPLY
