APAC Regulatory Operations Leader: Submissions & Strategy

Avance Clinical Pty Ltd; Sydney; On-site; AUD 250,000 - 350,000; Full time

Job summary

Avance Clinical Pty Ltd is seeking a strategic Director, Regulatory Operations (APAC) to lead submissions and regulatory delivery across APAC, including TGA, Medsafe, MFDS, TFDA and FDA IND activities.

You will mentor the APAC team, partner with Regulatory Strategy, Medical Writing and cross‑functional groups to drive compliant, timely responses and continuous improvement of processes in a global CRO.

Qualifications

• 15+ years in biotechnology, pharmaceuticals and/or CRO environments.
• Proven experience leading regulatory submissions across multiple markets.
• Strong knowledge of ICH guidelines and data privacy requirements.
• Track record of authoring and managing regulatory documents.

Responsibilities

• Lead APAC Regulatory Operations team, including recruitment and performance management.
• Oversee Health Authority submissions across APAC regions (TGA, Medsafe, MFDS, TFDA, FDA IND).
• Develop and execute global regulatory strategies for clinical, nonclinical and CMC.
• Ensure timely, compliant eCTD publishing and lifecycle management.

Skills

Regulatory leadership

Global submissions

ICH guidelines

Stakeholder management

Team leadership

eCTD publishing

Regulatory strategy

Regulatory operations

Education

Master’s degree or equivalent

Tools

SharePoint

Adobe

eQMS

Salesforce

eTMF platforms

Job description

Avance Clinical Pty Ltd is seeking a strategic Director, Regulatory Operations (APAC) to lead submissions and regulatory delivery across APAC, including TGA, Medsafe, MFDS, TFDA and FDA IND activities.

You will mentor the APAC team, partner with Regulatory Strategy, Medical Writing and cross‑functional groups to drive compliant, timely responses and continuous improvement of processes in a global CRO.