Bayer
Job Purpose:
Ensuring that Bayer Consumer Health products are registered and maintained with the relevant regulatory authorities in South Africa and ROSA according to the applicable legislation and guidelines, and in compliance to quality requirements on release of medicine (and other categories; cosmetics, medical devices and food supplement) for sale in line with GMP, Bayer Policies and SOPs, supporting the local business growth by providing guidance to local & enterprise stakeholders and relative functions on the regulatory strategy as well as issues and risks, representing BCH RA as a competent and reliable partner to the relevant competent authorities and stakeholders.
Key Tasks and Responsibilities:
Dossier Management: prepare, and submit new product registration dossiers, providing RA assessment on variations and ensure its compliant submission to regulatory bodies in a timely manner.
Compliance & Strategy: Ensure products meet local (e.g. SAHPRA, BoMRA, NMRC, MCAZ, ZAMRA etc.) and international regulatory standards; monitor legislative changes and provide strategic advice.
Liaison & Communication: Act as the main point of contact with health authorities and collaborate with internal teams (QA, Medical, PV, Marketing, R&D, Supply Chain).
Documentation Review: Approve and review packaging, labelling, promotional materials, and internal SOPs for compliance.
Lifecycle Management: Manage post-registration activities, including updates, audits, and responding to queries from authorities.
Regulatory Intelligence: Keep abreast of new trends, guidance, and regulatory intelligence to inform business decisions
Key working relations:
Local, Cluster, Enterprise & Global Regulatory, Medical, and RMSQC/R&D team
Country Commercial Lead and respective management team
Local Marketing, Medical, PV & Quality
External: health authority & trade associations
Required Qualifications:
Education: A Bachelor of Pharmacy (B.Pharm)
Registration: Must be a registered pharmacist with the South African Pharmacy Council (SAPC).
Proven track record in Regulatory Affairs with at least 2 years of 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.
Fluent in English
go to method of application »
Apply via company website ( ) or