Regulatory Affairs Specialist

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