Regulatory Affairs Specialist

**Job Description Summary** The RA specialist sets registration plan and perform product registration in accordance with registration and launch plan, and maintain product license with local regulation and global compliance strategy.   **Job Description** **Major accountabilities:** * **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   **Skills Desired** Clinical Trials, Collaboration, Detail-Oriented, Project Planning, Regulatory Compliance