Business Admin Learner | Regulatory Affairs at Novartis

Job Purpose

To provide support to the RA department to ensure timely submissions and approvals of amendments in line with the submission plan and to meet regulatory objectives.

These learnership opportunities means that the succesfull candidates will complete the Business Administration qualification (NQF 4. ID: 61595) and do workplace experience with the workplace company whilst at the same time complete the portfolio of evidence as prescribed by the learnership qualification.

Major Activities

• Understanding the Medicine Act and Pharmacy Act and the related Regulations and guidelines and how these influence the Regulatory Environment.
• Understanding the elements of the Marketing Code.
• Preparation and submissions of regulatory applications to SAHPRA.
• Proof reading of artwork components.
• Supporting compliance activities within the RA team
• Being an active member of the RA team, participating in all team activities, meetings and
• gathering.
• Support the RA team to meet its overall objectives.

Key Performance Indicators

• Efficient support has been provided to the RA department for compliance activities.
• All applications are submitted in line with the submission plan and meets all the requirements as specified by SAHPRA.
• Adherence to cGMP and SOPs.
• Training conducted according to program.
• Compliance with the relevant Act, Regulations, and guidelines.
• Compliance with all aspects of the Code of Conduct and Novartis Policies and Procedures.
• Living the Novartis values and behaviours.

Role Requirements

Education (minimum/desirable):

• Matric (grade 12) and Science degree.
• Honours or Master’s degree with exposure to Regulatory Sciences or experience in Regulatory Affairs will be an advantage.

Experience:

• Strong interpersonal and communication skills.
• Highly organized.
• Self-starter
• Ability to manage multiple projects and consistently meet deadlines.