EVERLYNNE NYAWIRA MAINNAH
Nairobi
Summary
Strategic Regulatory Affairs Manager with comprehensive experience in overseeing regulatory compliance and ensuring alignment with industry standards. Possess strong skills in managing product registrations, liaising with regulatory bodies, and developing effective risk management strategies. Demonstrated ability to deliver impactful results by streamlining processes, enhancing efficiency, and fostering collaborative relationships within cross-functional teams.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Drug Regulatory Consultancy
EVKA CONSULTZ LIMITED
05.2007 - Current
- Regulatory Strategy Development.
- Regulatory submission and lifecycle maintenance.
- Clinical Trial Support
- Pharmacovigilance and post-market surveillance.
- Communication with health authorities.
- Compliance Monitoring
- Training and Education.
- Risk Management
Senior Regulatory Affairs Manager, SSA
ASTRAZENECA
01.2023 - 06.2023
- Registration, Planning, and Business Support
- Implementation of GRP standards in the SSA Hub.
- Ensuring timely performance of regulatory processes, including marketing authorizations, license renewals, license maintenance, and pharmacovigilance activities.
- Developed and maintained relationships with regulatory agencies and industry stakeholders.
Drug Regulatory Consultancy
EVKA CONSULTZ LIMITED
10.2022 - 12.2022
- Registration of Pharmaceutical products, Veterinary products, medical devices, herbals, vaccines, radiopharmaceuticals and biologics for Kenya, Uganda, Tanzania, Ethiopia Rwanda and Zambia.
- Product Lifecycle management (Product Renewals, Retentions and Variations/ Notifications)
- Listing of food supplements, Borderline products
- Licensing and Advertisement approvals
- Report writing and communication with Principals on Regulatory matters.
- QMS setup and implementation. Training of staff on the same in line with GxP regulations.
- Submission and follow-up on import/ Export permits at the Pharmacy and Poisons Board.
- Follow up on lab analysis of products at the pre-qualified labs.
- Oversight of the PV system and all PV activities for the products for which the principal holds a Marketing Authorization. (QPPV)
- GxP Audits and Manufacturing site setups
- Regulatory intelligence
Regulatory Affairs Specialist
BD
04.2022 - 09.2022
- Securing Marketing Authorization for medical devices for East African Market
- Product lifecycle management (Renewals, retentions and variations)
- Liaising with the Business units in budgeting for products, preparation of product dossiers.
- Updating of reports on shared platforms and sharing the same with Marketing team
- Communication of any product quality complaints or reported adverse effects with product use to the Business unit heads and ensuring any Field safety actions are communicated with
Drug Regulatory Consultancy
SANOFI
12.2021 - 03.2022
- Report writing and communication with principals on regulatory matters.
- Securing Market Authorization transfers and product obsoletion in different markets
- Product Life cycle management- variations
Regulatory Affairs Head, East Africa
ASTRAZENECA
11.2020 - 05.2021
- Dossier preparation for new product(s) registration for Kenya, Uganda, Tanzania and Rwanda
- Product Lifecycle management (Renewals, Retentions and Variations)
- Participation in updates of artworks and product inserts.
- Update of products status on SharePoint and RIM
- Follow up on lab analysis of products at the pre-qualified labs.
- QPPV Kenya
Company Pharmacist and Head of Regulatory Affairs
SURGILINKS LIMITED
03.2006 - 04.2007
- Preparation of documents for Registration and Re‑registration of different companies from South Africa products.
- Ensuring compliance with regulatory requirements
- Follow up on Permits, Licenses and Advertising approvals.
- Formulating and training staff on various SOP’s (standard operating procedures)
- Initiated Training Policy of Medical Representatives.
- Writing Progress Reports
Regulatory Affairs Officer
REGAL PHARMACEUTICAL LIMITED
10.2005 - 02.2006
- Preparation of documents for Registration and Re‑registration of drugs in Kenya, Uganda, Tanzania, Rwanda, Zambia and Burundi.
- Ensuring compliance with regulatory requirements and GMP guidelines and liaising with the Pharmacy and Poisons Board on matters dealing with Licenses, Permits and Advertising.
- Setting up databases and handling matters to do with trademarks
- Supervision of intern training and student attachment.
- Writing Progress Reports
Hospital Pharmacist and Pharmacist In-Charge of Rural Health Facilities (RHF’s)
MERU DISTRICT HOSPITAL
01.2005 - 09.2005
- Head of pharmacy and the pharmacist in charge of Rural Health Facilities (RHF’s)
Education
Master’s in Executive Leadership (Magna Cum laude) - MBA
EXEED COLLEGE
Woolf, Malta12.2024
Pharmacovigilance & Pharmacoepidemiology - Postgraduate Diploma
JAMES LIND INSTITUTE
Switzerland06.2021
Master’s in Project Planning And Management - MA
UNIVERSITY OF NAIROBI
Nairobi12.2016
Master’s in Biotechnology, Innovation And Regulation - MSc
PURDUE UNIVERSITY
USA05.2016
Bachelor of Pharmacy -
UNIVERSITY OF NAIROBI
Nairobi05.2004
Skills
- Project management
- Product lifecycle management
- Pharmacovigilance
- Quality assurance
- Risk assessment
- Cross-functional collaboration
- Effective communication
- Training development
- Regulatory intelligence
- Cross-functional team leadership
- Regulatory submissions and compliance
- Crisis management
- Health authority negotiations
- GxP knowledge
- Global regulatory compliance
Certification
- GMP training by the German Medical Aid Organization (Action Medeor)
- Certificate in HIV/AIDS Management by the University of Washington, in conjunction with CDC Nairobi
- Online pharmacovigilance training by the WHO Uppsala Monitoring Centre
- Post Graduate Diploma in Industrial Pharmacy and Regulatory Affairs by Purdue University, Howard University, UNIDO, and Kilimanjaro School of Pharmacy, Moshi
- Collaborated with PSK and USP in setting up training programs on regulatory affairs and pharmacovigilance
- Certificates in Windows, MS Word, Excel, and PowerPoint
- Level One Diploma Certificate – French
Associations
- Member of PSK (Pharmaceutical Society of Kenya) - Head of Regulatory affairs committee, Member of legal and Veterinary medicine committees.
- Member of RAPSK (Regulatory Affairs Professional Society of Kenya) – Founding member and Current Organizing Secretary.
- Member of AFRAS (African Regulatory Affairs Specialists)
- Member International Society for Pharmacoepidemiology
- Member of MEDAK (Medical Devices Association of Kenya) – Founding member and Current Education and Training head.
Languages
English
First Language
Swahili
Upper Intermediate (B2)
B2
French
Elementary (A2)
A2
References
References available upon request.
Timeline
Senior Regulatory Affairs Manager, SSA
ASTRAZENECA
01.2023 - 06.2023
Drug Regulatory Consultancy
EVKA CONSULTZ LIMITED
10.2022 - 12.2022
Regulatory Affairs Specialist
BD
04.2022 - 09.2022
Drug Regulatory Consultancy
SANOFI
12.2021 - 03.2022
Regulatory Affairs Head, East Africa
ASTRAZENECA
11.2020 - 05.2021
Drug Regulatory Consultancy
EVKA CONSULTZ LIMITED
05.2007 - Current
Company Pharmacist and Head of Regulatory Affairs
SURGILINKS LIMITED
03.2006 - 04.2007
Regulatory Affairs Officer
REGAL PHARMACEUTICAL LIMITED
10.2005 - 02.2006
Hospital Pharmacist and Pharmacist In-Charge of Rural Health Facilities (RHF’s)
MERU DISTRICT HOSPITAL
01.2005 - 09.2005
Master’s in Executive Leadership (Magna Cum laude) - MBA
EXEED COLLEGE
Pharmacovigilance & Pharmacoepidemiology - Postgraduate Diploma
JAMES LIND INSTITUTE
Master’s in Project Planning And Management - MA
UNIVERSITY OF NAIROBI
Master’s in Biotechnology, Innovation And Regulation - MSc
PURDUE UNIVERSITY
Bachelor of Pharmacy -
UNIVERSITY OF NAIROBI
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