About this 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
Skills Desired Clinical Trials, Collaboration, Detail-Oriented, Project Planning, Regulatory Compliance