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Regulatory Affairs Associate
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Review pipeline and set the registration strategy in collaboration with global RA and related CPO functions with support from senior specialist and manager. 


**** Multiple locations available ****

  • 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


  • 4 years university degree preferably majored in pharmacy, (Bio)chemistry and life science
  • Fluent English
  • Experience in regulatory affairs 
  • experience in the healthcare industry (Pharmaceutical Industry preferred)

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


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