(Remote/WFH) Head of CMC Regulatory Strategy

• The strategist is responsible for finalizing the CMC, GMP regulatory strategies for assigned products/portfolio and support company FTEs to execute tasks independently in accordance with Japanese regulations and guidance, and client procedures.
  
  
•  Lead the Change control evaluation, preparation of submission strategies, identifying Japan's regulatory requirements and may manage a team of 6 to 8 members in support of project execution.
   
  
•  Lead & plan the appropriate regulatory strategy and execute regulatory tasks based on the information of change control initiated by the manufacturing department, proposed from the point of view of product supply and the situation of Product Assurance and Marketing.
   
  
• Must ensure all submissions are prepared in accordance with JP regulations. Serve as primary liaison with the Regulatory authorities (e.g., MHLW and/or PMDA) and interface on behalf of Freyr to negotiate as needed to support plans for new drug registrations and activities for existing product licenses. Leading preparation for and execution of Agency meetings.
   
  
• Lead & plan the geo-expansion strategy of the Active Marketed products portfolio of the client.
  
  
• Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
  
  
• For GMP inspection [PAI for NDA and PCA/Periodic] -: Provide the information on the manufacturing sites, etc. Listed in the application form for marketing approval to the lead department and provide support for the inspection.
  
  
• For Foreign Manufacturer Accreditation: lead and plan the registration for facility registration, preparing of package for PMDA consultation.
  
  
• Execute regulatory strategies by leading the development, Review and approval of CMC submission components and documentation to support post-approval supplements, and responses to health authority questions per established business processes and systems.
  
  
• Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
  
  
• Collaborate with Client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
   
  
• Demonstrate a robust understanding on J-NDA/J-ANDA (content development, assembly of the dossier, submission, through approval); post-marketing maintenance including re-examinations; JAN (Japanese accepted name) applications, expedited pathway applications and any other required submissions in Japan regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
  
  
• Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify, communicate, and escalate potential regulatory issues to management, as needed.
  
  
• Demonstrate ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
  
  
• Demonstrate flexibility in responding to changing priorities or dealing with unexpected events.
  
  
• Demonstrate effective leadership, communication, interpersonal and negotiating skills in the most complex and fast-paced team environments.
  
  
• Ability to lead a team of direct or matrix colleagues to deliver on business commitments and project timelines.
  

Requirements

Benefits