APAC Regulatory Operations Director: Submissions & Strategy

Avance Clinical Pty; Sydney; On-site; AUD 260,000 - 360,000; Full time

Job summary

Avance Clinical is seeking a Director, Regulatory Operations (APAC) to lead regulatory operations across APAC, overseeing submissions to TGA, MFDS, TFDA and FDA, and to drive lifecycle management and process improvements.

This senior role reports to the SVP Global Regulatory Operations, builds high-performing teams, partners with scientific strategy, medical writing and cross-functional groups, and ensures timely, compliant regulatory submissions worldwide.

Qualifications

• Master’s degree or higher in a relevant scientific field.
• Minimum 15 years’ experience in biotech/pharma/CRO environments.
• At least 10 years’ experience in regulatory submissions (ICH guidelines, FDA, etc.).
• Experience authoring and managing regulatory documents across clinical, preclinical and/or CMC.
• Experience with Health Authority communications and agency meetings.
• Experience with regulatory submission planning, eCTD publishing and lifecycle management.
• Knowledge of ICH E6/E3, M4S/E/E4 and FDA requirements.

Responsibilities

• Lead and develop the APAC Regulatory Operations team, including recruitment, performance management and resource planning.
• Provide strategic and operational oversight of APAC Health Authority submissions (planning, authoring, publishing, lifecycle).
• Develop and execute global regulatory strategies across clinical, nonclinical and CMC components.
• Support INDs, NDAs, BLAs and MAAs with eCTD preparation.
• Prepare for Health Authority meetings and ensure compliant submissions.

Skills

Leadership

Regulatory submissions

eCTD publishing

Stakeholder management

Education

Master’s degree or higher

PharmD/MD/PhD or equivalent

Tools

SharePoint

Adobe

eTMF platforms

Salesforce

Job description

Avance Clinical is seeking a Director, Regulatory Operations (APAC) to lead regulatory operations across APAC, overseeing submissions to TGA, MFDS, TFDA and FDA, and to drive lifecycle management and process improvements.

This senior role reports to the SVP Global Regulatory Operations, builds high-performing teams, partners with scientific strategy, medical writing and cross-functional groups, and ensures timely, compliant regulatory submissions worldwide.