Regulatory Affairs Pharmacist - 12 month contract

SUMMARY:

A global multinational manufacturer is seeking a Regulatory Affairs Pharmacist on a 12-month contract, responsible for ensuring that products are registered and maintained with the relevant regulatory authorities in South Africa and ROSA, in accordance with applicable legislation and guidelines, and in compliance with quality requirements for the release of medicines, cosmetics, medical devices, and food supplements for sale. The role supports local business growth by providing guidance to local and enterprise stakeholders and relevant functions on regulatory strategy, issues, and risks, while representing Regulatory Affairs as a competent and reliable partner to the relevant authorities and stakeholders.

POSITION INFO:

Minimum requirements for the role:

• Must have a Bachelor of Pharmacy (B. Pharm.)
• Must be a registered pharmacist with the South African Pharmacy Council (SAPC)
• Proven track record in Regulatory Affairs with at least 2 years' experience, including OTC medicines, complementary medicines, medical devices and cosmetics
• Experience in quality assurance is an added advantage
• Strong understanding of regulatory dossier (CTD/eCTD) requirements for all markets within scope
• Excellent scientific writing, communication, and interpretation skills
• Ability to work cross-functionally and manage projects
• Proactive, detail-oriented, and committed to continuous learning
• Must be fluent in English (Read, Write, Speak)

• Preparing and submitting new product registration dossiers, providing RA assessment on variations, and ensuring their compliant submission to regulatory bodies in a timely manner.
• Ensuring products meet local (e.g., SAHPRA, BoMRA, NMRC, MCAZ, ZAMRA) and international regulatory standards, monitoring legislative changes, and providing strategic advice.
• Acting as the main point of contact with health authorities and collaborating with internal teams (QA, Medical, PV, Marketing, R&D, Supply Chain).
• Approving and reviewing packaging, labelling, promotional materials, and internal SOPs for compliance.
• Managing post-registration activities, including updates, audits, and responding to queries from authorities.
• Keeping abreast of new trends, guidance, and regulatory intelligence to inform business decisions.