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.
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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.
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The organization is known for its strong pipeline, collaborative culture, and commitment to operational excellence across regions.
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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.
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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.
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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.
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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.
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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.
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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.
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This is a rare chance to elevate your career within a globally respected platform that values both expertise and ambition.
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If this sounds aligned with your experience or if you would like to explore the market more broadly, I would welcome a confidential conversation.
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📌 Senior Regulatory Affairs Specialist (New South Wales)
🏢 Barrington James
📍 New South Wales