APAC Regulatory Operations Director

Avance Clinical Pty; Sydney; On-site; AUD 220,000 - 320,000; Full time

Job summary

Avance Clinical Pty is seeking a strategic Director, Regulatory Operations (APAC) to lead the APAC regulatory submissions, operations, and team capability. You will partner with cross-functional teams to deliver high-quality regulatory submissions across APAC, US, and other markets.

The role requires senior leadership experience in regulatory affairs within a CRO or pharmaceutical environment, with a strong track record in eCTD publishing, lifecycle management, and regulatory strategy.

Qualifications

• Master’s degree or equivalent in a relevant scientific discipline
• 15+ years in biotechnology, pharmaceuticals or CRO environments
• 10+ years in regulatory submissions and agency interactions
• Experience managing Health Authority communications and meetings
• Knowledge of ICH guidelines and FDA regulations (21 CFR Parts 312/314)

Responsibilities

• Lead and develop the APAC Regulatory Operations team, including recruitment and performance management
• Provide strategic and operational oversight of APAC Health Authority submissions and lifecycle management
• Develop and execute global regulatory strategies across clinical, nonclinical and CMC
• Lead initial applications, amendments and ancillary submissions to APAC Health Authorities and support global submissions including US FDA INDs
• Oversee eCTD preparation and submission activities for INDs, NDAs and BLAs
• Prepare for and participate in Health Authority meetings (INTERACT, pre-IND, end-of-phase)
• Maintain up-to-date knowledge of regional and international regulatory requirements and guidance
• Drive SOPs and submission process improvements and resource planning
• Provide regulatory input into proposals, budgets and timelines
• Coordinate APAC Regulatory Operations meetings and report to senior management

Skills

Leadership

Regulatory operations

Team management

Global submissions

Regulatory strategy

Stakeholder management

Communication

Education

Master’s degree or equivalent

Tools

SharePoint

Adobe

eQMS

Salesforce

eTMF platforms

Job description

Avance Clinical Pty is seeking a strategic Director, Regulatory Operations (APAC) to lead the APAC regulatory submissions, operations, and team capability. You will partner with cross-functional teams to deliver high-quality regulatory submissions across APAC, US, and other markets.

The role requires senior leadership experience in regulatory affairs within a CRO or pharmaceutical environment, with a strong track record in eCTD publishing, lifecycle management, and regulatory strategy.