APAC Regulatory Operations Director

Avance Clinical; Australia; On-site; AUD 240,000 - 320,000; Full time

Job summary

Avance Clinical seeks a seasoned Director, Regulatory Operations (APAC) to lead regulatory activities across APAC including Australia, New Zealand, Korea, Taiwan and broader submissions to US FDA INDs. You will drive strategies, coordinate with cross-functional teams and mentor a high-performing regulatory operations group, ensuring timely, compliant submissions and continuous process improvement.

You will bring a track record of 15+ years in biotech/pharma/CRO, deep knowledge of ICH guidelines,

Qualifications

• Master's degree or equivalent in a scientific discipline.
• Minimum 15 years in biotechnology/pharma/CRO with regulatory submissions.
• Deep knowledge of global submission requirements and agency guidelines.
• Proven leadership of regulatory teams across regions.

Responsibilities

• Lead APAC Regulatory Operations and develop regional strategy.
• Oversee Health Authority submissions, planning, authoring and lifecycle management.
• Develop global regulatory strategies across clinical, nonclinical and CMC.
• Manage eCTD publishing, INDs, NDAs and MAAs for international filings.
• Mentor teams, manage resources and drive process improvements.

Skills

Leadership

Regulatory submissions

Team management

ICH guidelines

Cross-functional collaboration

Regulatory strategy

Education

Master's degree

Tools

SharePoint

Adobe

eTMF platforms

eQMS

Salesforce

Job description

Avance Clinical seeks a seasoned Director, Regulatory Operations (APAC) to lead regulatory activities across APAC including Australia, New Zealand, Korea, Taiwan and broader submissions to US FDA INDs. You will drive strategies, coordinate with cross-functional teams and mentor a high-performing regulatory operations group, ensuring timely, compliant submissions and continuous process improvement.

You will bring a track record of 15+ years in biotech/pharma/CRO, deep knowledge of ICH guidelines,