Kamogelo Moshwane
Regulatory Affairs
Johannesburg,GP
Summary
Enthusiastic Regulatory Affairs Personnel eager to contribute to team success through hard work, multi-tasking, working under pressure, adhering to deadlines and excellent organizational skills. Clear understanding of Drug Development Process, Clinical Trials, Drug Regulations and Pharmacovigilance. Motivated to learn, grow and excel in the Pharmaceutical Industry.
Overview
5
5
years of post-secondary education
2
2
years of professional experience
3
3
Certificates
Work History
Regulatory Affairs Officer
Bupo Animal Health (Pty) Ltd
Pretoria, Gauteng
10.2019 - Current
Regulatory Affairs Intern
Bupo Animal Health (Pty) Ltd
Pretoria, Gauteng
10.2019 - 09.2020
- Create, update, submit and maintain dossiers in CTD format for South Africa and Sub-Saharan Africa in accordance with the applicable regulations.
- Review clinical and technical documentation for regulatory compliance.
- Manage new and existing product registrations in South Africa and other African countries.
- Maintain approvals or licenses for existing marketing authorizations.
- Ensure product information labels, artwork and marketing leaflets are compiled with respective regulatory requirements.
- Reply to product queries, Regulatory Authorities and customers.
- Managing Product life cycle.
Education
Bachelor of Health Science (Honors) - Pharmacology
University Of The Witwatersrand
Johannesburg 01.2019 - 12.2019
Bachelor of Health Science - Biomedical Sciences
University Of The Witwatersrand
Johannesburg 02.2015 - 12.2018
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Skills
CTD Dossier
Regulatory Submissions
Regulatory Compliance
Literature Review
Attention to detail
Multi-tasking
Computer
Working independently
Team player
Certification
Introduction to Pharmacovigilance, Uppsala Monitoring Center - 05/2020
Timeline
Regulatory Affairs Intern
Bupo Animal Health (Pty) Ltd
10.2019 - 09.2020
Regulatory Affairs Officer
Bupo Animal Health (Pty) Ltd
10.2019 - Current
Bachelor of Health Science (Honors) - Pharmacology
University Of The Witwatersrand
01.2019 - 12.2019
Bachelor of Health Science - Biomedical Sciences
University Of The Witwatersrand
02.2015 - 12.2018