Regulatory Affairs Officer at B. Braun Group

Job Summary

Reference Code ZAMW1122-83705

B. Braun Medical Pty Ltd based in Johannesburg, South Africa require the services of a Regulatory Affairs Officer to be based at our Head Office in Northriding, Johannesburg.

Duties and responsibilities

• Assist Regulatory Pharmacists with creating, updating, submissions and maintenance of product registration document (dossier) in accordance with the applicable regulations.
• Conduct administrative tasks within the regulatory department and maintain database of regulatory information.
• Ensure that all departmental administrative duties are carried out accurately and diligently.
• Ensure all dossiers are appropriately audited and superseded as per timelines.
• Maintain all trackers in the RA department.
• Maintain Safety Data Sheets.
• Request payments for RA department as per B. Braun processes.
• Maintain RA Department employees Job Files.
• Assist in the compilation and submission of dossiers to Regulatory Authorities.
• Assist in compilation and co-ordination of submission of variations for currently marketed products.
• Coordinating responses to the regulatory authority committee recommendations (clinical, P&A, naming and scheduling and inspectorate) timeously, in accordance with guidelines and under the supervision of the Pharmacist.
• Assist Regulatory Pharmacist with the coordination of responses to Global Regulatory Affairs (GRA) department queries timeously, to satisfy the requirements of the business.
• Ensure that the master dossiers and copies thereof, are stored, maintained, and controlled in accordance with the relevant SOP.
• Ensuring that the agreed timelines are continuously being met.
• Compile and submit new product applications for designated export territories, as well as minor or major variations needed for these territories.
• Updating of PI and PIL leaflets to follow latest SAHPRA guidelines.
• Compile RA section of PQR’s.

Professional competencies

• At least 2-3 years pharmaceutical experience with specific focus areas in RA Affairs.
• BSc Degree or equivalent with science background will be an advantage.
• Computer literate with basic Microsoft (incl excel) experience.
• Basic administrative skills.
• Keep abreast with all guidelines, regulations and legislations.
• Knowledge of the Regulatory requirements for medical products of all countries with which B. Braun ZA affiliates with.

Personal competencies

• Results and performance driven – deliver results that meet or exceed expectations.
• Takes initiative and accountability.
• Integrity.
• Highly motivated.
• Intellectual curiosity – willing to suggest and try new ideas.
• Positive and pro-active approach to business tasks.
• Excellent interpersonal and communication skills.
• Positive ‘can – do’ attitude.
• Honest and trustworthy.
• Respectful and highly personable.