Regulatory & Pharmacovigilance (PV) Senior Manager
Regulatory & Pharmacovigilance (PV) Senior Manager
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Job Description
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.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
