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Senior Regulatory Start Up Associate - Australia

SeniorFull-timeHybridMelbourne VIC, AustraliaPosted 7 months agoVerified 3 days ago
Pending fitX of Y 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.

Key criteria

📄

Regulatory knowledge and experience

3-5 years of experience in regulatory submissions and approvals.

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🗣️

Effective communication skills

Confident English communication, both written and verbal.

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💻

IT application proficiency

Experience working across multiple IT applications and databases.

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5 criteria for this job
Regulatory knowledge and experience
3-5 years of experience in regulatory submissions and approvals.

View

Effective communication skills
Confident English communication, both written and verbal.

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

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Relevant educational background
Graduate in clinical, pharmacy, or life sciences field.

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Understanding of local regulations
Knowledge of country-specific regulations and practices.

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