Director, Regulatory Affairs

Avance Clinical Pty; Sydney; On-site; AUD 220,000 - 320,000; Full time

Job summary

Avance Clinical Pty is seeking a strategic Director, Regulatory Operations (APAC) to lead the APAC regulatory submissions, operations, and team capability. You will partner with cross-functional teams to deliver high-quality regulatory submissions across APAC, US, and other markets.

The role requires senior leadership experience in regulatory affairs within a CRO or pharmaceutical environment, with a strong track record in eCTD publishing, lifecycle management, and regulatory strategy.

Qualifications

• Master’s degree or equivalent in a relevant scientific discipline
• 15+ years in biotechnology, pharmaceuticals or CRO environments
• 10+ years in regulatory submissions and agency interactions
• Experience managing Health Authority communications and meetings
• Knowledge of ICH guidelines and FDA regulations (21 CFR Parts 312/314)

Responsibilities

• Lead and develop the APAC Regulatory Operations team, including recruitment and performance management
• Provide strategic and operational oversight of APAC Health Authority submissions and lifecycle management
• Develop and execute global regulatory strategies across clinical, nonclinical and CMC
• Lead initial applications, amendments and ancillary submissions to APAC Health Authorities and support global submissions including US FDA INDs
• Oversee eCTD preparation and submission activities for INDs, NDAs and BLAs
• Prepare for and participate in Health Authority meetings (INTERACT, pre-IND, end-of-phase)
• Maintain up-to-date knowledge of regional and international regulatory requirements and guidance
• Drive SOPs and submission process improvements and resource planning
• Provide regulatory input into proposals, budgets and timelines
• Coordinate APAC Regulatory Operations meetings and report to senior management

Skills

Leadership

Regulatory operations

Team management

Global submissions

Regulatory strategy

Stakeholder management

Communication

Education

Master’s degree or equivalent

Tools

SharePoint

Adobe

eQMS

Salesforce

eTMF platforms

Job description

Lead APAC regulatory operations for a global CRO

Avance Clinical is a leading Australian-founded, global Contract Research Organisation (CRO), supporting biotechnology and pharmaceutical companies to progress high-quality clinical development programs.

We are seeking an experienced and strategic Director, Regulatory Operations (APAC) to lead our APAC Regulatory Operations function. This is a senior leadership role responsible for regional Health Authority submissions, operational delivery, team capability, resource management and the continuous improvement of regulatory processes.

Reporting to the Senior Vice President, Global Regulatory Operations, you will be the senior technical Regulatory Operations contact for APAC and work closely with global colleagues, clients and cross-functional teams to deliver high-quality regulatory submissions across multiple international markets.

About the role

• Therapeutic Goods Administration (TGA) — Australia
• Medsafe — New Zealand
• Ministry of Food and Drug Safety (MFDS) — South Korea
• Taiwan Food and Drug Administration (TFDA) — Taiwan
• US Food and Drug Administration (FDA), including IND-related activities

You will partner with Scientific & Regulatory Strategy, Medical Writing, Medical Monitoring, Business Development and other functional teams to develop and execute effective regulatory strategies for our clients and their clinical development programs.

Key responsibilities

• Lead, mentor and develop the APAC Regulatory Operations team, including recruitment, performance management, training and resource planning.
• Provide strategic and operational oversight of APAC Health Authority submissions, including planning, authoring, compilation, publishing, submission and lifecycle management.
• Develop and execute global regulatory strategies across clinical, nonclinical and Chemistry, Manufacturing and Controls (CMC) components.
• Lead initial applications, amendments and ancillary submissions to APAC Health Authorities and support global submissions, particularly US FDA IND applications.
• Support eCTD preparation and submission activities for INDs, NDAs, BLAs, MAAs and equivalent international filings.
• Prepare for and participate in Health Authority meetings, including INTERACT, pre-IND and end-of-phase meetings.
• Ensure regulatory submissions meet country-specific formatting, quality, compliance and timeline requirements.
• Maintain up-to-date knowledge of regional and international regulatory requirements, agency guidance and ICH standards.
• Drive process improvement through the development and maintenance of SOPs, work instructions, templates and submission workflows.
• Provide regulatory input into proposals, budgets, timelines and bid-defence presentations.
• Support internal and external sponsor and regulatory audits.
• Coordinate APAC Regulatory Operations meetings and provide updates to senior management.

About you

You are a highly experienced regulatory affairs or regulatory operations leader with a strong understanding of global submission requirements and a proven ability to lead teams in a biotechnology, pharmaceutical or CRO environment.

You will bring:

• A Master’s degree, PharmD, MD, PhD or equivalent experience in a relevant scientific discipline.
• A minimum of 15 years’ experience in biotechnology, pharmaceuticals and/or CRO environments.
• At least 10 years’ experience in regulatory submissions, including knowledge of Agency regulations, ICH guidelines and data privacy requirements.
• Demonstrated experience authoring and managing regulatory documents across clinical, preclinical and/or CMC disciplines.
• Experience managing Health Authority communications, including preparation for and attendance at Agency meetings.
• Experience with regulatory submission planning, eCTD publishing and lifecycle management.
• Working knowledge of ICH E6, ICH E3, ICH M4, M4Q, M4S and M4E.
• Knowledge of FDA requirements, including 21 CFR Parts 312 and 314.
• Strong people leadership, mentoring, stakeholder management and resource planning skills.
• Excellent communication, organisation, analytical and problem-solving capability.
• Confidence working independently, collaboratively and across global, cross-functional teams.

Highly regarded

• Regulatory submission experience in Australia, New Zealand, South Korea, Taiwan, Singapore and/or Malaysia.
• Knowledge of Chinese regulatory pathways and processes.
• Experience with TFDA, MFDS, HSA and/or NPRA submissions.
• Mandarin language capability, written and spoken.
• Experience with SharePoint, Adobe, project-management tools, eQMS, Salesforce and eTMF platforms.

Why join Avance Clinical?

At Avance Clinical, you will join a collaborative, science-led organisation supporting the development of innovative new medicines and therapies.

This is an opportunity to:

• Lead and shape the APAC Regulatory Operations function.
• Work on complex, high-value APAC and global regulatory submissions.
• Partner with experienced regulatory, scientific, medical writing and clinical research professionals.
• Influence regulatory strategy, operational excellence and team capability in a growing global CRO.
• Build a meaningful career in an organisation committed to quality, collaboration and continuous improvement.

Avance Clinical is an equal opportunity employer. We are committed to fostering an inclusive workplace and welcome applications from people of diverse backgrounds, experiences and perspectives.