Senior Regulatory Affairs Specialist

Barrington James; Australia; On-site; AUD 100,000 - 150,000; Full time

Job summary

Barrington James is seeking a Senior Regulatory Affairs Study Start Up Specialist in Australia to join a globally established clinical research organization. This pivotal role will involve leading the preparation and submission of clinical trial applications and supporting clinical development programs. The successful candidate will have a strong track record in regulatory affairs or clinical research, possess excellent communication skills, and bring a proactive mindset to navigate complexities of the role. This is an exceptional opportunity to influence the success of innovative therapies worldwide, while collaborating with diverse teams and mentoring junior staff.

Qualifications

• Solid track record in regulatory affairs or clinical research.
• Hands-on experience managing submissions across different regions.
• Proven ability to influence clinical development timelines.

Responsibilities

• Lead the preparation and submission of clinical trial applications.
• Oversee regulatory documentation and engage with ethics committees.
• Drive alignment across stakeholders for seamless study activation.
• Provide expert guidance on regulatory pathways.

Skills

Regulatory affairs expertise

Strong communication skills

Proactive mindset

Ability to navigate complexity

Job description

I am currently partnering with a globally established clinical research organization to appoint a Senior Regulatory Affairs Study Start Up Specialist into a pivotal role supporting international clinical development programs.

This is an exceptional opportunity to join a high performing environment where regulatory expertise directly influences the speed and success of bringing innovative therapies to patients worldwide.

The organization is known for its strong pipeline, collaborative culture, and commitment to operational excellence across regions.

This role offers the chance to take full ownership of complex study start up activities across multiple countries, working at the intersection of regulatory strategy and execution.

You will lead the preparation and submission of clinical trial applications, oversee regulatory documentation, and engage directly with ethics committees and health authorities to secure timely approvals.

Acting as a key partner to global project teams, you will provide expert guidance on regulatory pathways, anticipate challenges, and drive alignment across stakeholders to ensure seamless study activation.

Beyond execution, this position offers strong strategic exposure, including the opportunity to contribute to regional and global submission strategies and, where applicable, step into a global regulatory lead capacity for assigned studies. You will be part of a dynamic and forward thinking team, collaborating with cross functional experts while mentoring junior colleagues and supporting audit readiness.

The role is well suited for individuals who enjoy both the detail oriented nature of regulatory work and the broader impact of influencing clinical development timelines.

I am looking to speak with professionals who bring a solid track record in regulatory affairs or clinical research, with hands on experience managing submissions across different regions. A proactive mindset, strong communication skills, and the ability to navigate complexity with confidence will be key to thriving in this environment.

This is a rare opportunity to elevate your career within a globally respected platform that values both expertise and ambition.

If this sounds aligned with your experience or if you would like to explore the market more broadly, I would welcome a confidential conversation.