Sr. RA Specialist

 Review pipeline and set the registration strategy in collaboration with global RA and related CPO functions independently
 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 (registrational) database (DRAGON)
 Ensure industry compliance with NP4, KRPIA code of conduct
 Support cross functional activities by delivering regulatory input
 Have extensive understanding on the legal frameworks, internal processes, GxP’s
 Keep abreast of relevant laws /regulations and apply to related CPO activities
 Understand regulatory affairs as it applies throughout the product lifecycle
 Participate in regulatory environment shaping activities e.g. TFT etc.
 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 and negotiate effectively with HA and other BFs
 Share experience with Specialists on technical aspects and scientific understanding plus project management skill
 Streamline RA internal working process