Liz Mwangi
Nairobi
Summary
Regulatory Affairs Specialist
Dedicated and results-driven professional with a strong background in Regulatory Affairs. Highly skilled in regulatory submissions, planning and management, Stakeholder collaboration and regulatory compliance.I am eager to leverage my skills in a dynamic environment, fostering innovation and excellence in regulatory processes and strategies for overall business success.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Specialist Sub-Sahara Africa
Medtronic
01.2018 - 10.2021
- Executed regulatory submissions ensuring compliance with PPB, TFDA, EFDA, UNDA, NAFDAC, and Ghana FDA.
- Facilitated communications with health authorities throughout new product review processes.
- Collaborated with cross-functional teams to develop and implement regulatory strategies.
- Implemented a registration plan to comply with new medical device e-registration guidelines, effective in Jan 2019.
- Reviewed proposed product changes to determine a market-appropriate regulatory strategy, and identify operational impact.
- Developed responses to regulator inquiries about product safety and efficacy.
- Submitted notifications of product changes to regulatory agencies.
- Coordinated recall or market withdrawal activities.
- Maintained up-to-date knowledge of industry regulations and guidelines.
- Organized and maintained all files related to regulatory actions.
- Updated in-depth trackers of approvals and submissions.
Africa Regulatory Affairs Associate
GlaxoSmithKline Limited
08.2015 - 03.2017
- Ensured optimal regulatory compliance levels for Africa.
- Reviewed labeling and promotional materials for regulatory compliance and accuracy.
- Maintained comprehensive documentation for regulatory filings and submissions.
- Developed and maintained Africa regulatory KPIs and metrics dashboard to track compliance performance.
- Championed labeling compliance initiatives in Africa, ensuring end-to-end adherence to regulatory standards.
- Coordinated the annual license renewals for African markets.
- Updated detailed approval trackers for regulatory submissions. of approvals and submissions.
- Performed internal quality audits on systems and regulatory processes, resulting in corrective and preventive actions to enhance compliance.
- Provided training and guidance on regulatory policies to internal teams.
- Trained and provided ongoing support to the Africa regulatory team on OPAL, the global regulatory database.
Regulatory Affairs Project Trainee
GlaxoSmithKline Limited
09.2014 - 07.2015
- Submitted registration application dossiers for six products in Uganda, Tanzania, and Madagascar.
- Submitted product variations to regulatory authorities for approval.
- Collaborated with international colleagues to prepare a submission package for local markets.
- Collaborated with local technical representatives to implement regulatory strategies in the market.
- Ensured license compliance by conducting timely re-registrations and renewals.
- Organized and maintained compliance documentation for regulatory submissions. and maintained records for compliance and quality assurance.
- Developed knowledge of industry regulations and guidelines through extensive reading and practical training.
Marketing Executive
Crown Paints East Africa Limited
04.2014 - 08.2014
- Developed and executed comprehensive marketing plans to increase brand awareness and generate leads.
- Promoted crown paint and waterproofing products directly to construction experts to generate leads.
- Provided continuous education to experts on existing and new products, and their applications.
- Sponsored annual architects and QS conventions for opportunities to promote products and services directly
- Prepared detailed marketing forecasts on daily, weekly and quarterly basis.
- Established and maintained effective communications channels with stakeholders to ensure transparency and alignment on marketing initiatives.
Sales Representative
Sadolin Paints East Africa Limited
Nairobi
08.2012 - 03.2014
- Cultivated commercial relationships to sustain existing sales and drive new business growth.
- Facilitated customer orders to enhance overall satisfaction and streamline service.
- Informed customers about different Sadolin paint products and their applications.
- Ensured the availability of products through timely stock orders aligned with the demand patterns at the store.
- Maintained up-to-date stock and sales records.
- Received and documented customer complaints to ensure timely resolution. and worked with relevant teams to resolve them.
Education
Bachelor of Science - Industrial Chemistry
KENYATTA UNIVERSITY
Nairobi, Kenya01.2012
Skills
- CTD Dossier preparation
- Regulatory compliance
- Project planning and management
- Submission management
- Cross-functional collaboration
- Risk assessment
- Regulatory intelligence
- Quality systems
Certification
Project Management Fundamentals - International Institute of Learning, Inc
Key Achievements
- Completed 200+ online product registrations at Medtronic to comply with new e-registration requirements in Kenya, effective Jan 2019
- Completed product submissions for 20+ Medtronic products across Tanzania, Ethiopia, and Ghana, with more than 50% approvals secured as of Feb 2021
- Developed the Africa metrics dashboard displaying KPI scores, which was adapted as a way of working for the GSK regulatory function in Africa and the Middle East, Asia
- Led a labelling compliance initiative for GSK consumer goods thereby averting product recalls worth up-to £22 million.
- Championed quality compliance by developing a guidance document and RACI on the management of safety updates for wellness and nutritional products across Africa
- Led the regulatory integration of Novartis brands across Africa after a GSK-Novartis merger in July 2015 by ensuring the timely submission of outstanding labeling information to ensure compliance, and hence, business continuity
- Nominated OPAL regulatory database champion for Africa in 2015 following a successful review and organization of registration and submission information for GSK consumer products across East Africa
Timeline
Regulatory Affairs Specialist Sub-Sahara Africa
Medtronic
01.2018 - 10.2021
Africa Regulatory Affairs Associate
GlaxoSmithKline Limited
08.2015 - 03.2017
Regulatory Affairs Project Trainee
GlaxoSmithKline Limited
09.2014 - 07.2015
Marketing Executive
Crown Paints East Africa Limited
04.2014 - 08.2014
Sales Representative
Sadolin Paints East Africa Limited
08.2012 - 03.2014
Bachelor of Science - Industrial Chemistry
KENYATTA UNIVERSITY