Overview
Regulatory Affairs Associate (FTC) Jobs in Midrand, Gauteng, South Africa at Novartis
Title: Regulatory Affairs Associate (FTC)
Company: Novartis
Location: Midrand, Gauteng, South Africa
Summary
Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.
About The Role
Major accountabilities:
Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with Fuse, BeSure, code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, drug safety reporting etc.) -Foster and maintain good relations with internal and external stakeholders. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
Minimum Requirements
Registered with the SAPC. Min BPharm Degree
Work Experience
Regulatory experience min 3-5 years. Able to create and submit eCTDs.
Functional Breadth.
Cross Cultural Experience.
Operations Management and Execution.
Project Management.
Skills
Analytical Skill.
Collaboration.
Detail Oriented.
Lifesciences.
Project Planning.
Regulatory Compliance.
Languages
English.
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
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
