Regulatory Affairs Associate (FTC)
Regulatory Affairs Associate (FTC)
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description 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.Job Description
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 35 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:
Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. to Diversity and Inclusion:
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here:
Desired
Required Experience:
IC
Employment Type
Full-Time
