APAC Regulatory Operations Lead - Strategy & Submissions

Avance Clinical; Sydney; On-site; AUD 180,000 - 260,000; Full time

Job summary

Avance Clinical in Australia seeks a seasoned Director, Regulatory Operations (APAC) to lead regulatory activities across Australia, New Zealand, Korea and Taiwan, plus broader US FDA IND submissions. You will set strategy, coordinate with cross-functional teams and mentor a high-performing regulatory operations group to ensure timely, compliant submissions.

You bring 15+ years in biotech/pharma/CRO and deep knowledge of ICH guidelines, with a proven track record in process improvement and

Qualifications

• 15+ years in biotech/pharma/CRO with regulatory operations experience.
• Deep knowledge of ICH guidelines and global submission practices.
• Proven ability to lead cross-functional teams and drive process improvements.

Responsibilities

• Lead regulatory activities across APAC including Australia, NZ, Korea and Taiwan.
• Coordinate with cross-functional teams to ensure timely, compliant submissions.
• Mentor and develop a high-performing regulatory operations group.

Skills

Regulatory operations leadership

Cross-functional coordination

Mentoring high-performing teams

Job description

Avance Clinical in Australia seeks a seasoned Director, Regulatory Operations (APAC) to lead regulatory activities across Australia, New Zealand, Korea and Taiwan, plus broader US FDA IND submissions. You will set strategy, coordinate with cross-functional teams and mentor a high-performing regulatory operations group to ensure timely, compliant submissions.

You bring 15+ years in biotech/pharma/CRO and deep knowledge of ICH guidelines, with a proven track record in process improvement and