Regulatory Affairs | People with Disability Learnership

Summary

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.

About The Role

Major accountabilities:

• 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.

Minimum Requirements

• Minimum: Matric (grade 12), BPharm or Science degree. Honours or Masters degree with exposure to Regulatory Sciences or experience in Regulatory Affairs will be an advantage.

Skills

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

Languages

• English.

The Companys approved Employment Equity Plan and Targets will be considered as part of the recruitment process. As an Equal Opportunities employer, we actively encourage and welcome people with various disabilities to apply. Novartis recognises, appreciates and values diversity & inclusion.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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