About THESYL

THESYL is a Contract Research Organization (CRO) dedicated to advancing Clinical Research, Pharmacovigilance, and Regulatory services across Africa. We work with clients across the globe to bring safe, effective, and high-quality health products to market, and ensure their continued safety post-registration.

Internship Overview

We’re looking for one or two curious and detail-oriented Regulatory Affairs Interns to join our team. The ideal candidates will have a strong interest in pharmaceutical regulations, the ability to navigate complex regulatory systems, and the capability to work independently with minimal supervision.

As an intern, you’ll contribute to real projects, helping us with regulatory intelligence, market analysis, and document preparation for product registrations, clinical trials, and pharmacovigilance compliance across Rwanda, Kenya, Tanzania, Uganda, Burundi, and DR Congo.

This is a unique opportunity to deepen your understanding of regulatory science and contribute to meaningful health access initiatives in Africa. The role is remote but requires on-site presence in Kigali a few days per month.

Key Responsibilities

1. 1. Regulatory Intelligence
   • Product Registration
     • • Monitor and summarize updates from African NRAs, including Rwanda FDA, Kenya PPB, Tanzania TMDA, Uganda NDA, Burundi ABREMA, DR Congo ACOREP, etc.
     • • Analyze market entry requirements, fees and timelines for product registration in assigned countries.
     • • Research and summarize reimbursement mechanisms and pathways in designated countries.
     • • Create comparative overviews of regulatory requirements (e.g., differences in dossier requirements, timelines, and fees) for product registrations across target countries.
   • Clinical Trials
     • • Research and summarize regulatory requirements for clinical trial in target countries.
     • • Assist in preparing comparative analyses of clinical trial regulations, timelines, and fees across regions.
     • • Track updates to clinical trial guidelines and their impact on client projects.
   • Pharmacovigilance
     • • Monitor updates to pharmacovigilance regulations and guidelines in target countries.
     • • Assist in preparing summaries of pharmacovigilance requirements for post- marketing safety monitoring.
     • • Contribute to comparative analyses of pharmacovigilance systems across regions.
   • General Regulatory Intelligence
     • • Draft internal memos and briefing notes to summarize key regulatory changes and their potential impact on client projects.
     • • Evaluate mutual recognition of approvals and bilateral MoUs among African regulators (e.g., Rwanda FDA, Tanzania TMDA, Kenya PPB, Ghana FDA).
2. 2. Dossier Preparation Support
   • • Assist in developing regulatory strategies and submission plans.
   • • Review CTD dossiers (Modules 1-5) for formatting and completeness.
   • • Help with document version control and tracking submission components.
   • • Contribute to checklists for technical and administrative requirements.
   • • Update regulatory review and submission trackers.
3. 3. Market Analysis & Strategy
   • • Analyze regulatory pathways for different product categories (generics, biologics, herbal, etc.).
   • • Prepare briefing notes on requirements for specific countries or/and product types.
   • • Identify potential regulatory hurdles and propose mitigation strategies.
4. 4. Communication & Documentation
   • • Draft formal letters, meeting minutes, and email correspondence to authorities (under guidance).
   • • Contribute to internal documentation processes and knowledge databases.
   • • Prepare slide decks and reports for internal and client-facing presentations.
5. 5. Other responsibilities
   • • Contribute to regulatory planning discussions and document outcomes.
   • • Assist in developing templates and Standard Operating Procedures (SOPs) to standardize regulatory deliverables.

Ideal Candidate Profile

• ✓ Be a citizen or legal resident of Rwanda
• ✓ 5th-year pharmacy student ( or 4th-year Pharmacy student with strong academic acumen).
• ✓ Strong interest in pharmaceutical regulations, drug safety, and clinical trials.
• ✓ Demonstrates initiative and accountability, with strong problem-solving abilities.
• ✓ Strong written and verbal communication skills in English; proficiency in French is highly desirable. Swahili is an asset.
• ✓ Comfortable working remotely and independently while maintaining consistent communication.
• ✓ Analytical mindset with attention to detail and curiosity to explore how systems work.
• ✓ Meticulous, with the ability to synthesize information from diverse sources.
• ✓ Familiarity with basic regulatory concepts (CTD format, pharmacovigilance, GxP standards) is a plus, but not mandatory.
• ✓ Initiative-taker.

Working Style

We offer a flexible and collaborative environment that encourages ownership and data-driven decision-making. Our interns are expected to

• Integrity: Demonstrate honesty and transparency in all tasks, ensuring that information is handled responsibly, and decisions are made with ethical consideration.
• Maintain Confidentiality: Safeguard all client and regulatory data, respecting confidentiality agreements and company policies regarding sensitive information. Interns will be required to sign a confidentiality agreement upon joining.
• Take ownership of tasks and suggest improvements.
• Communicate openly and reliably.
• Uphold professionalism in all client- and regulator-facing interactions.

We will provide mentorship, performance feedback, and opportunities to explore additional areas of interest such as pharmacovigilance, health systems research, or digital regulatory tools, depending on performance and alignment.

What You’ll Gain

• • Exposure to real-world regulatory challenges in African markets.
• • Practical experience preparing regulatory documents and conducting policy research.
• • Insight into regional harmonization efforts
• • A chance to contribute to impactful work improving access to safe medicines.
• • Opportunities to contribute to health research and drug development projects, playing a role in advancing scientific knowledge and improving healthcare outcomes.

Application Process

Please send the following to [application link]:

• • A brief cover letter explaining your interest in the role and your relevant experience.
• • Your CV (max 2 pages).
• • Optional: A writing sample (e.g., short paper, report, or memo). Applications are reviewed on a rolling basis. Shortlisted candidates will be invited for a short interview and practical tasks