Job Description

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.

Minimum Requirements:

Education:

Science degree with Honours or master's degree. 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.

NB: In order to be considered for the learnership:

Your application must be supported by a motivational letter and your academic transcripts Must be a South African Citizen. Ages between 18 - 35 Years.

Languages :

English.

Novartis South Africa is committed to promoting equity (race, gender, and disability) through the filling of this post with a candidate whose transfer/promotion/appointment will promote representivity in line with the numerical targets as contained in our Employment Equity plan. While we are prioritizing designated groups, our selection process will still be based on the most suitable candidate, with the necessary skills and experience, as outlined in the job description.

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

Benefits and Rewards:

Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards



Division
Development
Business Unit
Development
Location
South Africa
Site
Midrand
Company / Legal Entity
ZA01 (FCRS = ZA001) Novartis SA (Pty) Ltd.
Functional Area
Others
Job Type
Full time
Employment Type
Early Career (Fixed Term)
Shift Work
No