Institute Overview

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.
• Interprets substantive review questions, decisions, conditions, restrictions, permits, waivers and post-approval obligations.
• 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

• Investigation-product or medicine preparation.
• Dispensing and accountability.
• Rescue-medicine or antidote management; and
• 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.
• Experience engaging investigators, sponsors, CROs, regulators, ethics committees, permit bodies and multidisciplinary institutional stakeholders.

Preferred Language Skill :

• Clear written and verbal communication (English & Swahili).

• 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.
• Interprets substantive review questions, decisions, conditions, restrictions, permits, waivers and post-approval obligations.
• 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 Investigation-product or medicine preparation, Dispensing and accountability, Rescue-medicine or antidote management, and Pharmaceutical support during emergency treatment.

• Investigational-product or medicine preparation skills.

• Postgraduate degree or Bachelor degree in pharmacy, public health, clinical epidemiology, epidemiology, clinical research, clinical trials, clinical pharmacology or a demonstrably related field.