APAC Regulatory Operations Director

Avance Clinical Pty Ltd; North Sydney Council; On-site; AUD 250,000 - 320,000; Full time

Job summary

Avance Clinical is seeking a Director, Regulatory Operations (APAC) to lead regulatory activities across APAC, including submissions to TGA, Medsafe, MFDS, TFDA and FDA-related activities. You will partner with Strategy, Medical Writing and Clinical teams to drive regulatory strategy and lifecycle management.

The role requires senior leadership, strong expertise in submissions, and a track record of delivering high-quality regulatory outcomes in biopharma/CRO environments.

Qualifications

• Senior regulatory operations leader with global submission experience.
• Experience drafting and managing regulatory documents across clinical, preclinical and CMC.
• Strong knowledge of ICH guidelines and agency regulations.

Responsibilities

• Lead APAC Regulatory Operations across multiple markets.
• Oversee health authority submissions and lifecycle management.
• Mentor and grow regional team capabilities.
• Collaborate with cross-functional teams to shape regulatory strategies.

Skills

Regulatory leadership

APAC regulatory

Regulatory submissions

Team leadership

eCTD publishing

Strategic communications

Education

Master’s degree, PharmD, MD, PhD or equivalent

Tools

SharePoint

Adobe

eQMS

eTMF platforms

Job description

Avance Clinical is seeking a Director, Regulatory Operations (APAC) to lead regulatory activities across APAC, including submissions to TGA, Medsafe, MFDS, TFDA and FDA-related activities. You will partner with Strategy, Medical Writing and Clinical teams to drive regulatory strategy and lifecycle management.

The role requires senior leadership, strong expertise in submissions, and a track record of delivering high-quality regulatory outcomes in biopharma/CRO environments.