About The Role

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

Review pipeline and set the registration strategy in collaboration with global RA and related CPO functions with support from senior specialist and manager
Achieve the best product registration with optimal label by conducting research on submission requirements and approval lead time in accordance with registration plan.
Support launches (artwork, barcode, Drug ID mark, etc.)
Perform CTA and get approval to ensure study timeline in collaboration with other CPO functions.
Support IMP management through confirmation of variant number.
Maintain product license by managing variations for label, quality (CMC and mfg. site) and administrative changes according to local law/regulation/guidelines, company strategy and global compliance.
Secure product license by managing Reevaluation/Renewal/Reexamination /HA safety communication
Ensure post approval activities (website, artwork, etc.)
Submit RMP by supporting of other function in line with global direction.
Be accountable for correct and timely update of RA compliance (registration) database (DRAGON)
Ensure industry compliance with NP4, KRPIA code of conduct
Support cross functional activities by delivering regulatory input
Understand basic knowledge on the legal frameworks, internal processes, GxP’s
Keep abreast of relevant laws /regulations and apply to related CPO activities
Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis products according to respective SOP
Foster and maintain good relations with internal and external stakeholders.
Communicate effectively with HA and other BFs
Understand RA internal working process and handle own task well

Essential Requirements

Education: 4-year university degree, preferably in Pharmacy, Biochemistry, Chemistry, Life Sciences, or a related field
Languages: Fluent in both written and spoken English
Experience: Pharmaceutical industry experience preferred
Knowledge: Basic understanding of regulatory affairs, drug development process, and applicable pharmaceutical regulations/guidelines preferred