Regulatory Affairs Specialist M/F - 260

In the context of our growing activities, we are looking for a Regulatory Affairs Specialist M/F to join our teams in South Africa.

You will integrate a team of Regulatory Affairs professionals dedicated to one of our new main clients across the globe and will have the mission to develop PLG’s local South Africa Regulatory Affairs presence, taking responsibility for new regulatory activities related to South Africa for this main client and other several clients.

• Regulatory in country affiliate activities
• Local stakeholder interface
• Operational liaison with 3rd Parties
• Regulatory Assessment for Quality and Safety changes (including labelling updates and non CMC administrative changes)
• Creation/update of Country Label Deviation
• Update and approval of local artworks
• Provision of local regulatory intelligence
• Update of local site licenses (GMP site renewals)
• Regulatory review of local promotional materials via PromoMats
• Local Regulatory SOP review and update
• Regulatory activities for new launches (preparation of Marketing Authorization Applications)
• Coordination of Response to Questions
• Preparation/update Product Information
• Preparation /update local abbreviated PI (if applicable)
• Fee calculation
• Preparation of Renewal Procedure (eg. local document identification and preparation)
• Preparation for Variations including. RtQs, requesting/securing centrally provided documentation
• Preparation and submission of Technical/Site Transfer Applications
• Regulatory support in relation to local requirements relating to cessation of marketing / sunset clause / withdrawal of MAs
• Assisting with license applications as required.
• Responding to internal requests for technical and/or regulatory information.
• Providing support during external and unannounced audits.
• Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
• General regulatory administration duties and compliance requirements
• Preparation for Annual Safety Updates/HA instructed safety updates
• Informing reliant markets of changes to reference product
• PQR local submissions (when applicable)
• Responding to requests from Medical information (when applicable)
• Provision of regulatory data for PV reporting
• Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc

• At least a Bachelor’s Degree in Life Sciences, ideally a Pharmacy Degree

• At least 5 years of experience in RA in a Pharmaceutical Company or Service Provider
• South Africa LifeCycle Maintenance (LCM) experience
• Experience in the management of artwork generation/ labelling/creation/update of product information (at least 3-5 years)
• Experience in project management
• Experience in the new registrations of drug products is preferable
• Experience of Pharmacovigilance (PV) would be beneficial
• Experience of promotional/non-promotional activities would be an advantage (at least 3-5 years)

Hard/Technical skills:

• Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in South Africa and ideally in the EU region
• Knowledge of South African regulation for pharmaceuticals (NCE, Biologicals and Biotech) and ideally for Medical Devices, Combination products and Cosmetics
• Strong computer skills, including MS Office applications, data and document management systems
• Fluency in Afrikaans and English

Soft skills:

• Excellent communication skills
• Excellent organizational and interpersonal skills
• Very good coordination skills
• A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
• Ability to work well within a team and autonomously
• Ability to prioritize different workloads/multi-task
• Process orientated with good attention to detail
• Solution-driven