Regulatory Affairs Associate (ftc)
Midrand, Johannesburg, South Africa
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.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
- Regulatory experience min 3-5 years. Able to create and submit eCTDs.
- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.
- Analytical Skill.
- Collaboration.
- Detail Oriented.
- Lifesciences.
- Project Planning.
- Regulatory Compliance.
- English.
Our purpose is to reimagine medicine to improve and extend peoplexe2x80x99s 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:Youxe2x80x99ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.Commitment 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:Skills Desired Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance
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Job Detail
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Job IdJD1423108
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMidrand, Johannesburg, South Africa
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EducationNot mentioned