About the Role
MINIMUM REQUIREMENTS
- B.Pharm degree.
- Current registration and good standing with the South African Pharmacy Council (SAPC).
- Minimum of 2 years' pharmaceutical regulatory affairs experience within the South African human medicines environment.
- Proven experience independently compiling and submitting new product registration dossiers to SAHPRA.
- Working knowledge of CTD/eCTD requirements, SAHPRA guidelines and the SAHPRA submission portal.
- Hands-on experience with DocuBridge for eCTD compilation and publishing.
- Eligible and willing to be appointed as the company's Responsible Pharmacist.
- Sound knowledge of the Pharmacy Act, SAPC rules, Medicines and Related Substances Act and Good Wholesaling Practice (GWP).
- Experience with product variations, renewals and responding to SAHPRA queries.
- Valid driver's licence.
ADVANTAGEOUS EXPERIENCE
- Previous experience as a Responsible Pharmacist, preferably within a pharmaceutical wholesale or distribution environment.
- Experience across various therapeutic areas.
- Experience working with international manufacturers and reviewing regulatory dossiers.
- Knowledge of international GMP and regulatory standards.
- Medical device regulatory experience.
- Exposure to commercial processes requiring regulatory documentation.
KEY RESPONSIBILITIES
- Responsible Pharmacist & Compliance
- Fulfil the statutory responsibilities of the company's Responsible Pharmacist in accordance with the Pharmacy Act and SAPC rules.
- Ensure the company's premises registration and relevant pharmaceutical licences remain current.
- Oversee Good Wholesaling Practice (GWP), including the receipt, storage, handling and distribution of medicines and cold-chain products.
- Ensure only appropriately registered and authorised products are distributed.
- Maintain control and records of scheduled substances.
- Manage product recalls, quality complaints and adverse drug reaction reporting.
- Coordinate and support SAHPRA and SAPC inspections.
- Provide staff training on GWP and pharmacy compliance requirements.
- Notify the relevant regulatory authorities of changes as required.
- SAHPRA Applications & Product Registrations
- Compile, review and submit new product registration dossiers to SAHPRA in CTD/eCTD format.
- Review dossiers received from manufacturers and partners for completeness and South African regulatory compliance.
- Prepare responses to SAHPRA queries, deficiency letters and committee recommendations.
- Monitor submission progress and liaise with SAHPRA regarding outstanding applications.
- Product Lifecycle Management
- Manage and support post-registration variations, amendments, renewals and annual retention fees.
- Maintain approved package inserts, patient information leaflets and product labelling artwork.
- Assess regulatory implications of manufacturer changes, including manufacturing sites, formulations and product specifications.
- Licensing & Regulatory Compliance
- Support applications and amendments for company licences under the Medicines and Related Substances Act, including Section 22C licences.
- Maintain compliance with the Medicines Act, Pharmacy Act, SAPC rules and applicable SAHPRA guidelines.
- Support GMP/GWP compliance, supplier qualification, audits and inspections.
- Maintain accurate regulatory records, submission trackers and documentation.
- Medical Devices & Regulatory Intelligence
- Support SAHPRA medical device licensing and product listing requirements where applicable.
- Monitor regulatory developments in South Africa and other relevant African markets.
- Maintain professional working relationships with SAHPRA and international regulatory partners.
CORE COMPETENCIES
- High levels of integrity, professionalism and confidentiality.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills.
- Ability to work independently and manage multiple regulatory submissions.
- Excellent organisational and deadline-management skills.
- Commercial awareness and understanding of the impact of regulatory timelines on business operations.
- Proficiency in MS Office and document management systems.
REMUNERATION: Negotiable and market-related, commensurate with qualifications and experience.
PLEASE NOTE: This is an office-based position working hours of 08h00 – 17h00, Monday to Friday.