(Remote/WFH) CMC Regulatory Consultant

• Responsible for finalizing theCMC, GMP regulatory strategies for assigned products/portfolio and supportcompany FTEs to execute tasks independently in accordance with Japaneseregulations and guidance, and client procedures.
  
  
•  Lead the Change control evaluation, preparationof submission strategies, identifying Japan's regulatory requirements. 
  
•  Lead & plan the appropriate regulatorystrategy and execute regulatory tasks based on the information of changecontrol initiated by the manufacturing department, proposed from the point ofview of product supply and the situation of Product Assurance and Marketing.
   
  
• Must ensure all submissions are prepared inaccordance with JP regulations. Serve as primary liaison with the Regulatoryauthorities (e.g., MHLW and/or PMDA) and interface on behalf of Freyr tonegotiate as needed to support plans for new drug registrations and activitiesfor existing product licenses. Leading preparation for and execution of Agencymeetings.
   
  
• Lead & plan the geo-expansion strategy ofthe Active Marketed products portfolio of the client.
  
  
• Serve as the CMC Product Lead for assignedproducts and be accountable for the delivery of all regulatory milestones forassigned products through the product lifecycle.
  
  
• For GMP inspection [PAI for NDA andPCA/Periodic] -: Provide the information on the manufacturing sites, etc.Listed in the application form for marketing approval to the lead departmentand provide support for the inspection.
  
  
• For Foreign Manufacturer Accreditation: lead andplan the registration for facility registration, preparing of package for PMDAconsultation.
  
  
• Execute regulatory strategies by leading thedevelopment, Review and approval of CMC submission components and documentationto support post-approval supplements, and responses to health authorityquestions per established business processes and systems.
  
  
• Provide regulatory expertise as needed toproduct in-license/due diligence review, product divestment and productwithdrawal.
  
  
• Collaborate with Client and external partners tosupport compliant execution of change management and conduct all activitieswith an unwavering focus on regulatory conformance.
   
  
• Demonstrate a robust understanding onJ-NDA/J-ANDA (content development, assembly of the dossier, submission, throughapproval); post-marketing maintenance including re-examinations; JAN (Japaneseaccepted name) applications, expedited pathway applications and any otherrequired submissions in Japan regulatory affairs and apply this understandingto the benefit of the company to ensure approval and Product supply continuity.
  
  
• Assess and communicate potential regulatoryrisks and propose mitigation strategies. Deliver all regulatory milestones forassigned products across the product lifecycle Identify, communicate, andescalate potential regulatory issues to management, as needed.
  
  
• Demonstrate ability to generate innovativesolutions to complex regulatory problems and effectively work with andcommunicate to key stakeholders.
  
  
• Demonstrate flexibility in responding tochanging priorities or dealing with unexpected events.
  
  
• Demonstrate effective leadership, communication,interpersonal and negotiating skills in the most complex and fast-paced teamenvironments.
  
  
• Ability to lead a team of direct or matrixcolleagues to deliver on business commitments and project timelines.
  

Requirements

Benefits