Job Description
Lead APAC regulatory operations for a global CRO
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10th September, ****
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Avance Clinical is a leading Australian-founded, global Contract Research Organisation (CRO), supporting biotechnology and pharmaceutical companies to progress high-quality clinical development programs.
n 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.
n 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.
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n About the role
n In this role, you will lead regulatory operations activities across APAC, with particular focus on submissions to:
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Therapeutic Goods Administration (TGA) — Australia
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Ministry of Food and Drug Safety (MFDS) — South Korea
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Taiwan Food and Drug Administration (TFDA) — Taiwan
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US Food and Drug Administration (FDA), including IND-related activities
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10th September, ****
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Avance Clinical is a leading Australian-founded, global Contract Research Organisation (CRO), supporting biotechnology and pharmaceutical companies to progress high-quality clinical development programs.
n 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.
n 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.
n
n About the role
n In this role, you will lead regulatory operations activities across APAC, with particular focus on submissions to:
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Therapeutic Goods Administration (TGA) — Australia
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Medsafe — New Zealand
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Ministry of Food and Drug Safety (MFDS) — South Korea
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Taiwan Food and Drug Administration (TFDA) — Taiwan
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US Food and Drug Administration (FDA), including IND-related activities
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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.
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Key responsibilities
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Lead, mentor and develop the APAC Regulatory Operations team, including recruitment, performance management, training and resource planning.
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Provide strategic and operational oversight of APAC Health Authority submissions, including planning, authoring, compilation, publishing, submission and lifecycle management.
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Develop and execute global regulatory strategies across clinical, nonclinical and Chemistry, Manufacturing and Controls (CMC) components.
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Lead initial applications, amendments and ancillary submissions to APAC Health Authorities and support global submissions, particularly US FDA IND applications.
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Support eCTD preparation and submission activities for INDs, NDAs, BLAs, MAAs and equivalent international filings.
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Prepare for and participate in Health Authority meetings, including INTERACT, pre-IND and end-of-phase meetings.
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Ensure regulatory submissions meet country-specific formatting, quality, compliance and timeline requirements.
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Maintain up-to-date knowledge of regional and international regulatory requirements, agency guidance and ICH standards.
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Drive process improvement through the development and maintenance of SOPs, work instructions, templates and submission workflows.
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Provide regulatory input into proposals, budgets, timelines and bid-defence presentations.
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Support internal and external sponsor and regulatory audits.
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Coordinate APAC Regulatory Operations meetings and provide updates to senior management.
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About you
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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.
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You will bring:
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A Master's degree, PharmD, MD, PhD or equivalent experience in a relevant scientific discipline.
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A minimum of 15 years' experience in biotechnology, pharmaceuticals and/or CRO environments.
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At least 10 years' experience in regulatory submissions, including knowledge of Agency regulations, ICH guidelines and data privacy requirements.
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Demonstrated experience authoring and managing regulatory documents across clinical, preclinical and/or CMC disciplines.
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Experience managing Health Authority communications, including preparation for and attendance at Agency meetings.
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Experience with regulatory submission planning, eCTD publishing and lifecycle management.
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Working knowledge of ICH E6, ICH E3, ICH M4, M4Q, M4S and M4E.
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Knowledge of FDA requirements, including 21 CFR Parts 312 and 314.
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Robust people leadership, mentoring, stakeholder management and resource planning skills.
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Excellent communication, organisation, analytical and problem-solving capability.
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Confidence working independently, collaboratively and across global, cross-functional teams.
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Highly regarded
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Regulatory submission experience in Australia, New Zealand, South Korea, Taiwan, Singapore and/or Malaysia.
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Knowledge of Chinese regulatory pathways and processes.
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Experience with TFDA, MFDS, HSA and/or NPRA submissions.
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Mandarin language capability, written and spoken.
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Experience with SharePoint, Adobe, project-management tools, eQMS, Salesforce and eTMF platforms.
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Why join Avance Clinical?
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At Avance Clinical, you will join a collaborative, science-led organisation supporting the development of innovative new medicines and therapies.
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This is an opportunity to:
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Lead and shape the APAC Regulatory Operations function.
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Work on complex, high-value APAC and global regulatory submissions.
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Partner with experienced regulatory, scientific, medical writing and clinical research professionals.
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Influence regulatory strategy, operational excellence and team capability in a growing global CRO.
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Build a meaningful career in an organisation committed to quality, collaboration and continuous improvement.
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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.

📌 Director, Regulatory Operations (New South Wales)
🏢 Avance Clinical Pty
📍 New South Wales