Apac Regulatory Operations Director

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 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,

APAC Regulatory Operations Director Sydney, NSW, AU