Regulatory & Pharmacovigilance (PV) Senior Manager

At Medison, we are a purpose-driven, global biotech company committed to bringing life-changing therapies to people living with rare and severe diseases. We believe that access to the best available treatments should not be limited by geography - and we are here to make that belief a reality.

As we continue to expand across international markets, we’re building a world-class team in Australia and New Zealand - and we’re looking for an experienced Regulatory & Pharmacovigilance (PV) Senior Manager to lead these critical functions in the region.

Why Join Us?

• Make real impact: Play a pivotal role in bringing rare disease and oncology therapies to patients who need them most.
• Shape the future: Be part of a fast-growing, agile company where your voice and expertise influence decisions.
• Grow with us: Thrive in a high-trust, high-performance culture that values curiosity, collaboration, and innovation.
  
  

Responsibilities:

As the Regulatory & PV Senior Manager, ANZ, you’ll lead both the strategic and operational execution of all regulatory affairs and pharmacovigilance activities across Australia and New Zealand.

What You’ll Do:

Regulatory Affairs (RA)

• Develop and lead local RA strategies to support TGA and Medsafe submissions.
• Maintain up-to-date knowledge of regulatory changes across ANZ, advising both local and global stakeholders.
• Drive end-to-end submission processes, including PI and CMI updates, promotional material review, and local compliance.
• Lead vendor selection and oversight where third-party RA support is needed.
• Provide strategic input on pipeline products and new opportunities.
  
  

Pharmacovigilance (PV)

• Serve as local Qualified Person for Pharmacovigilance (QPPV) for the TGA.
• Build and maintain a fully compliant PV system, in line with both local and global regulations.
• Oversee collection, processing, and reporting of safety data to regulatory authorities.
• Manage local PV vendors and safety agreements (SDEAs/PVAs).
• Lead PV inspection readiness, internal audits, and training across the affiliate.
  
  

Leadership & Strategy

• Represent RA & PV as a member of the ANZ Management Team.
• Act as a key advisor on cross-functional initiatives including Market Access, Medical Affairs, and Commercial.
• Foster a culture of operational excellence, continuous improvement, and ethical integrity.
  
  

Requirements:

What You Bring:

• 7+ years of Regulatory Affairs experience in prescription medicines (rare disease/biotech preferred).
• Proven experience managing TGA and/or Medsafe submissions.
• PV experience; QPPV designation or equivalent a strong advantage.
• Strong working knowledge of global and local PV systems, safety data, and regulatory frameworks.
• Experience in vendor management, auditing, and working in a matrix environment.
• Comfortable navigating ambiguity and lean structures in a high-growth environment.
• Strategic mindset with the ability to zoom in on the details when needed.
• Collaborative spirit and a drive to challenge the status quo with purpose.
  
  

Ready to join a company where you can make a difference from Day One?

Apply now and help us rewrite the future of rare disease and oncology treatment in Australia, New Zealand - and beyond.

Medison is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.