# Regulatory Affairs PharmacistThis job is published by an external platform.| | || --- | --- || Location | Gauteng, South Africa || Contract | Full time || Work Model | Remote || Closing | in about 2 months |**Our well-established client in the pharmaceutical industry has a vacancy available for a Regulatory Affairs Pharmacist to be based at the Parktown office.** **Main Purpose of Job** To fulfil the position of regulatory affairs pharmacist within any division within the group. **Key Performance Areas (Core, essential responsibilities –outputs of the position)** • Responsible for new product applications. • Compilation and submission of Post –Registration amendments to ensure dossier compliance. • Responsible for pre and post-registration SAHPRA Committee recommendation responses to ensure product registration. • Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation • To ensure approval and compliance of printed packaging material and promotional marketing material. • Liaising with the marketing department to facilitate the timely launch of products. • Approval of master batch documentation prior to product production. • Responsible for SOP implementation/review, update and compliance. • Managing and maintaining the regulatory documentation filing system. • Ensuring regulatory compliance and quality-related records are available and retained. • Ensure ongoing regulatory compliance of the existing product portfolio. • Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products • Liaise with business development for regulatory requirements prior to dossier acquisition. • Training and peer review of documents **Minimum Requirements** **EDUCATION** * **Bachelor of Pharmacy Degree****EXPERIENCE** * Minimum 2 years’ experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan**SKILLS/PHYSICAL COMPETENCIES** Docubridge Sage Smartsheet Sweet process Microsoft: Excel, Word, PowerPoint, Outlook **BEHAVIOURAL QUALITIES** Takes ownership. Integrity, bound to principles, confidentiality, and ethics. Strong leadership skills. Good communication skills. Good organisational skills. Good planning skills. Good follow-up skills Attention to detail Assertive. Conscientious. Patient. Co-operative. Deadline Driven **DESIRABLE SKILLS & EXPERIENCE:** * 2 Years’ experience in regulatory affairs and attention to detailCollaboration: Refers to formal and informal relationships. **Responsibility towards:** • Responsible Pharmacist • Procurement • Marketing • NBD General working conditions (e.g., shift work, driver’s license, specific tools, special clothing, environmental requirements, etc.) • Office-based/For International remote **Travel** • SAHPRA • Suppliers **Please attach cv, qualifications, id and drivers license**#J-18808-Ljbffr