Regulatory Affairs Associate (Ftc)

About the RoleMajor accountabilities :Contribute to and support the development of submissions for product registration, progress reports, supplements, amendments, and periodic experience reports.Support all registration activities within the Department to ensure compliance with local pharmaceutical regulatory requirements.Responsibilities include:Achieving optimal product registration with commercially attractive labeling in accordance with the registration plan.Maintaining and securing product licenses, including CMC / CDS / safety updates, according to local regulations, laws, guidelines, company strategy, and global compliance.Ensuring compliance with Fuse, BeSure, the code of conduct, and relevant regulations and laws for related CPO activities (DRAGON updates, RMP, packing materials, promotional activities, drug safety reporting, etc.
).Fostering and maintaining good relationships with internal and external stakeholders.Reporting technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.Qualifications:Regulatory experience of at least 3-5 years, with the ability to create and submit eCTDs.Functional breadth and cross-cultural experience.Operations management and execution skills.Skills : Analytical skills, project planning, regulatory compliance.Languages : Please specify language requirements here.Why Novartis :Helping people with disease and their families requires more than innovative science.
It takes a community of smart, passionate people like you.
Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients' lives.Ready to create a brighter future together?Learn moreJoin our Novartis Network : Not the right role for you?
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