Remote Regulatory Intelligence Mgr, Global RA with verification

To enhance our Regulatory Team, argenx is seeking a highly motivated Regulatory Intelligence Manager. This role is crucial for ensuring our awareness and compliance with upcoming changes, new legislation, guidelines, and regulations relevant to our products and business. The successful candidate will be instrumental in monitoring and analyzing the regulatory and competitive landscape, providing recommendations to maintain compliance, stay ahead of industry trends and ensure our strategies remain innovative and effective. Additionally, this role will support all functional areas. The ideal candidate will excel in building and maintaining strong collaborative partnerships with both internal and external stakeholders.

Roles And Responsibilities

• Identify and permanently monitor the information needs of the internal stakeholders.
• Participate in the external environment parsing, extracting relevant information.
• Analyze and interpret changes to the regulatory landscape.
• Keep up to date with latest guidelines from Health Authorities e.g.: EMA, MHRA, FDA, PMDA and other Regulatory bodies e.g.: EU Commission, ICH, ISO, etc...
• Prepare the concise and comprehensive reports/summaries/presentations/newsletters on regulatory updates for communication with internal stakeholders.
• Liaise with all functional areas of the organization and if applicable argenx vendors on RI matters.
• Identify and maintain an internal network of SMEs across Functional Areas and Geographies as needed to support RI activities.
• Work in collaboration with the RI related SME(s) and quality group to support gap analysis, risk assessment and strategize proposals for implementation of regulatory changes. Identify and classify potential risks and opportunities arising from regulatory landscape changes.
• Develop a full set of standardized tools, templates and methods to support the RI activities as well as their inter-correlation with the internally gathered regulatory intelligence.
• Participate in the selection, testing and implementation of RI specific tools as they are brought in.
• Depending on areas of expertise, participate in external regulatory intelligence networks, forums and conferences to voice argenx positions if relevant, bring back relevant information for internal dissemination and proactively keeping abreast with Industry’s best practices.
• If applicable, coordinate argenx feedback on health authorities consultations or other regulatory landscape changes.
  
  
  

Educational Background

Desired Skills & Experience:

• Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field with strong understanding of the global health authority regulations framework.
  
  
  

Experience

• 5-10 years of experience in biopharmaceutical industry with at least 5 years of experience in a regulatory intelligence function. US region RI experience being a must.
• Proven track record of monitoring and interpreting regulatory changes and their impact on the organization.
  
  
  

Technical Skills

• Hands-on knowledge of Regulatory Intelligence methods, typical databases and tools. Knowledge and understanding of the GenAI technology being a plus.
• Ability to monitor trends, detect shifts in requirements and align internal organization priorities and actions accordingly.
• Strong project management and prioritization skills, proven ability to effectively manage multiple tasks and priorities in a fast paced environment.
  
  
  

Interpersonal Skills

• Strong communication and networking skills to identify and maintain an internal network of subject matter experts (SMEs).
• Collaborative mindset to work effectively with SMEs and Quality groups.
  
  
  

Other

• Analytical mindset, attention to details.
• Perfect command of English.