Regulatory affairs specialist - 1-year fixed term contract

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.