Regulatory Affairs Manager

4 weeks ago

Sydney, New South Wales, Australia Heng & Hurst Full time
Regulatory Affairs Manager | Rare Disease | SYD

Join to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & Hurst

Regulatory Affairs Manager | Rare Disease | SYD

1 day ago Be among the first 25 applicants

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This global, research-driven biopharma company specialises in developing innovative therapies for patients with high unmet medical needs. Since launching their Australian affiliate, they've continued to grow rapidly, delivering strong commercial and clinical performance with a robust product pipeline and new indications on the horizon.

This newly created position offers the opportunity to take full ownership of regulatory affairs across ANZ. Reporting to the Operations Director and working closely with global and local teams, this role is pivotal in ensuring the successful development, approval, and lifecycle management of innovative medicines in the region.

Key Responsibilities

  • Lead the development and execution of strategic regulatory submission plans and support new registrations
  • Liaise with TGA and Medsafe, acting as the primary contact for meetings, submissions, and query management
  • Collaborate with global regulatory teams to prepare and submit high-quality dossiers and ensure launch readiness - Maintain regulatory documentation and GMP clearance in alignment with SOPs and local requirements
  • Provide regulatory input into business development, cross-functional projects, and product lifecycle changes
  • Oversee QA operations, maintain accurate quality records, manage training programs, and ensure documentation compliance
  • Manage third-party vendors and monitor performance against KPIs

What You'll Bring

  • Extensive experience in Regulatory Affairs within the Australian pharmaceutical industry
  • In-depth understanding of TGA and Medsafe processes, GxP standards, and local regulatory and compliance requirements
  • Proven ability to lead cross-functional projects, manage stakeholders, and influence regional strategy
  • Excellent communication, problem-solving, and project management skills
  • A proactive mindset with strong attention to detail and accountability

This is a rare opportunity to shape the regulatory and quality landscape for a growing affiliate. You'll be trusted to work independently, make meaningful decisions, and play a key role in bringing innovative treatments to patients in need. By working closely with a dynamic leadership team, you'll strengthen the foundation of a growing organisation. On offer is a supportive leadership team, collaborative culture, well-resourced global infrastructure, and a truly flexible working environment.

To apply for this role please submit your application in WORD format by clicking 'apply'; or contact Jasmine Garbino on 0460947804 for further enquiries. Confidentiality is assured.

Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionScience
  • IndustriesPharmaceutical Manufacturing and Medical Equipment Manufacturing

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