Regulatory Affairs Officer

4 days ago

Johannesburg, South Africa Brenntag Full time

**Regulatory Affairs Officer**: Our team in **Johannesburg** currently has an opening for a **Regulatory Affairs Officer** > **YOUR ROLE & RESPONSIBILITIES**: - To co-ordinate and perform Regulatory Affairs activities as per statutory pharmaceutical/GMP requirements, liaising with our vendors as required. Providing a regulatory service to our internal and external customers, mainly in the Life Science / Pharma sector. **Pharma & Complementary Medicines (CM) Documentation / Projects**: - Keep up-to-date with legislation/ regulations/ guidelines pertaining to the pharma and CMs industry - Foster good customer relationships and manage Pharma / CM project lists for key customers - Handle complex customer requests for documentation needed to approve raw materials and/or compile CTD dossiers (CMs, DMF / CEP) for submission to SAHPRA - Liaise with vendors as required to meet customer / regulatory requirements including audits **Quality Mailbox**: - Manage response to queries received from internal and external customers **Controlled / sensitive / trademarked materials**: - Manage control of controlled/sensitive substances and trademarked items in SAP (“Legal control”) - Customer vetting **Compliance**: - Support QA team in implementing and maintaining regulatory compliance measures at BSA - Facilitate ethical trade memberships & audits e.g. SEDEX, Rainforest Alliance **General**: - Agency / Distributor projects e.g. trademark licence agreements - Assist in training colleagues in other departments on regulatory topics - Provide ad hoc assistance and cover for colleagues in the Quality & Regulatory department - Adhere to company Health and Safety procedures and report any incidents to the Health and Safety Representative in your department, or the site Safety Officer - Carry out any reasonable and lawful instruction as may be given by Management from time to time. **YOUR PROFILE**: - Matric- Tertiary qualification in Life Science- Min 5 years’ experience in pharmaceutical / complementary industry- Experience in Quality Assurance/Food Safety would be an advantage- Experience in creating CTD dossiers for submission to MCC / SAHPRA preferred- Sound understanding of South African regulatory environment **OUR OFFER**: > **INTERESTED?**:

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