Regional Regulatory Lead - Oncology (EU Remote)

The Opportunity

We are partnering with a growing, innovation-driven pharmaceutical company focused on advancing its oncology portfolio across multiple regions.

This is a unique opportunity to join at a pivotal moment of expansion, contributing to the development of complex oncology programs with global impact. The role offers strong exposure to cross-functional collaboration and strategic regulatory decision-making in a dynamic and fast-paced environment.

The Role

As a Regional Regulatory Lead, you will play a key role in defining and executing regulatory strategies across assigned products and regions, with a strong focus on oncology. You will work closely with global and regional stakeholders to ensure successful regulatory submissions and approvals, supporting both early and late-stage development programs.

Key Responsibilities

• Define and implement regulatory strategies for assigned products and regions
• Contribute to global regulatory planning across complex oncology programs
• Collaborate with cross-functional teams (clinical, R&D, regulatory, external partners)
• Lead or support interactions with regulatory authorities
• Oversee preparation and submission of regulatory documents (e.g., MAAs, CTAs)
• Ensure compliance with regional and global regulatory requirements
• Monitor regulatory trends and competitor landscape to inform strategy
• Manage submission timelines and ensure timely approvals
  
  

Profile

• Strong experience in Regulatory Affairs within Oncology (mandatory)
• Proven experience with EU regulatory submissions (e.g., MAA, CTA)
• Experience working in regional or global roles within a matrix environment
• Ability to navigate complexity and ambiguity in a fast-evolving environment
• Strong stakeholder management and communication skills
• Hands-on, proactive mindset with a strong sense of ownership
  
  

Why this role?

• Opportunity to join a growing oncology-focused organization
• Exposure to global regulatory strategy and high-impact programs
• Dynamic, collaborative, and agile environment
• Strong visibility and influence within cross-functional teams
  
  

If you are looking to take the next step in your Regulatory Affairs career within Oncology and want to make a real impact in a growing organization, we would love to hear from you!

Fill in the form, we will contact you...