Global Senior Regulatory Start-Up Lead

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

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.