Regulatory Affairs Associate - Elanco Animal Health
(2023-02)
- Led the end-to-end process for new product applications, ensuring comprehensive and accurate submissions.
- Compiled and submitted post-registration amendments, maintaining strict dossier compliance.
- Managed renewals and variations for an extensive portfolio of existing products.
- Developed and provided critical pre and post-registration recommendations to secure timely product registrations.
- Ensured ongoing regulatory compliance by meticulously updating dossiers, Product Information (PI), and Patient Information Leaflets (PIL) in alignment with current legislation.
- Managed and maintained the regulatory documentation filing system efficiently using Veeva Vault RIM.
- Reviewed and approved all artwork and labeling content through the Blue publishing system.
- Approved printed packaging material, promotional, and advertising marketing content via the Blue publishing system, ensuring regulatory adherence.
- Collaborated effectively with the Marketing department to facilitate the timely launch of new products.
- Analysing regulatory documents and legislation, securing all necessary documentation for authority submissions.
Independent Contractor Regulatory Affair Officer - Pharma Intelligence
(2022-02 - 2022-03)
- Compiled and submitted post-registration variations (Type 1A, 1B, Type 11) to SAHPRA.
- Managed the compilation and submission of PI/PIL updates (Type 1A, 1B, Type 11).
- Performed translation and proofreading of artwork and labels.
- Reviewed promotional materials for compliance.
- Compiled labels for CAMS and Cosmetics.
- Conducted due diligence and full gap analysis of medicine/CAMS dossiers.
Regulatory Affairs Officer - Virbac RSA
(2012-11 - 2021-07)
New products registration, existing product maintenance, compliance with product registration and legislation so as to make possible for VIRBAC to market products in RSA where product registration and regulation is required using Act 101 of 1965 department of health (SAHPRA), Act 36 of 1946 department of Agriculture Act 35 of 1984 for (G- registration and V registration) and other African countries (Zimbabwe, Zambia, Kenya, Namibia, Tanzania, Botswana and Mozambique)
- Managed Renewals and amendments of existing products
- Applied for Import Permits under the Animal Disease Act 35 of 1984
- Reviewing documents and legislation and obtain required documentations for submission to authorities
- Develop, update and writing of SOP's, change control procedures, Documentation management & Product queries and also involved in Annual Product Quality Review system.
- Reviewing and Approval of Promotional items, Advertising (Involve in a new project for Electronic detailing following the new guideline to the Code of Marketing Practise) and Artwork in accordance with the current Health Authority regulation.
Specification Specialist - Specpharm Holdings
(2011-06 - 2012-10)
- Prepared and secured approval for stability protocols, logging samples in line with these protocols.
- Evaluated stability programs to ensure alignment with customer technical agreements and arranged microbiological samples for tablets.
- Generated and updated raw material, intermediate, finished product, and stability specifications, liaising with clients and regulatory departments.
- Standardized raw materials according to MBR1/MRF1 and latest compendia.
- Prepared and validated analytical test methods, ensuring availability of necessary standards and columns.
- Maintained MBR1/MRF1 files and communicated with customers for updates.
- Updated SOPs related to job specifications and adhered to safety, health, and environmental policies.
- Acted as backup for the microbiologist.
Regulatory Affairs Officer - Bioclones Cell Culture Division
(2010-09 - 2011-05)
- Compiled dossiers for South Africa (MRF1 Format), Nigeria, Zimbabwe, Mauritius, Taiwan, Ghana, and Mozambique.
- Managed Quality Management Systems and Quality Assurance processes.
- Oversaw Production Management and tracked all African country submissions.
- Handled all payments for registration, amendments, renewals, and authentication fees, maintaining updated databases.
- Managed country correspondences, drafted letters to agencies, and followed up on submissions.
- Coordinated sample requests from the plant for medicine registration.
- Responsible for electronic and hardcopy filing per country and product.
- Applied for Certificates of Pharmaceutical Product (CPP's).
Regulatory Affairs Co-ordinator - Aspen Pharmacare
(2007-12 - 2010-08)
- Compiled dossiers for Namibia (MRF1 Format), Nigeria, Zimbabwe, Kenya, Tanzania, and Uganda (eCTD Format for harmonized regions).
- Managed trackers for all African countries.
- Processed payments for registration, amendments, renewals, and authentication fees, and updated databases.
- Handled country correspondences, drafted letters to agencies, and followed up on submissions.
- Coordinated sample requests from the plant for medicine registration.
- Managed electronic and hardcopy filing per country and product.
- Organized couriering of staff and updated databases with tracking information.
- Applied for Certificates of Pharmaceutical Product (CPP's).
Regulatory Affairs Co-ordinator - Pharma Natura
(2006-12 - 2007-11)
- Managed change control, including compiling dossiers and converting MBR to MRF format.
- Processed payments for registration, amendments, renewals, and authentication fees, and updated databases.
- Handled country correspondences, drafted letters to agencies, and followed up on submissions.
- Coordinated sample requests from the plant for medicine registration.
- Managed electronic and hardcopy filing.
- Assisted with compliance of product dossier information.
- Reviewed and approved promotional items, advertising, artwork, and drafted SOPs.
Chemical Analyst - Adcock Ingram R & D
(2005-12 - 2006-01)
- Analyse raw materials, finished products, and stability products.
- Ensured calibration and proper functioning of measuring instruments, including HPLC, GC, UV, and Dissolution baths.
Chemical Analyst - Novartis SA
(2005-02 - 2005-11)
Chemical Analyst - Schering Plough
(2004-04 - 2005-01)
Chemical Analyst - Aspen Pharmacare East London
(2000-10 - 2004-03)
