Director, Regulatory Operations

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 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. Avance-PD_Director-Regulatory-Operations-APAC-final.docx

About the role

In this role, you will lead regulatory operations activities across APAC, with particular focus on submissions to:

• 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.

• 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.