Novotech5 jobs

Senior Regulatory Start Up Associate - Australia

SeniorFull-timeHybridMelbourne VIC, AustraliaProfessional servicesPosted 1 month ago
View your fit0 of 9 criteria met

About the job

The Senior Regulatory Start Up Associate plays a crucial role in ensuring timely clinical trial approvals by managing country and site level ethics and regulatory authority applications. This job is all about collaboration and communication, working closely with project managers and regulatory teams to navigate the complexities of clinical research. The team values flexibility and inclusivity, offering a supportive environment where everyone can thrive.

You'll be responsible for

📞

Serving as primary contact

Acting as the main point of contact for the Regulatory Start-Up Manager and/or Project Manager during start-up on allocated projects.
🔍

Providing expertise

Offering guidance on country and local regulations, keeping up with developments in clinical trial approvals.
⏳

Managing submission timelines

Ensuring compliance with forecasted submission/approval timelines and updating systems accurately.

What we're looking for

📄

Regulatory experience in clinical trials

3-5 years of experience in CRO or pharmaceutical settings.

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🗣️

Confident communication skills

Strong English written and verbal communication abilities.

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💻

IT application proficiency

Experience working across multiple IT applications and databases.

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Meet the team

About the company

View your fit

0 of 5 criteria met
Regulatory experience in clinical trials
3-5 years of experience in CRO or pharmaceutical settings.

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Confident communication skills
Strong English written and verbal communication abilities.

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IT application proficiency
Experience working across multiple IT applications and databases.

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Knowledge of regulatory timelines
Understanding of submission deadlines for regulatory approvals.

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Familiarity with ICH-GCP
Knowledge of ICH-GCP and local regulatory requirements.

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