Regulatory Submission Specialist (18-months contract)
Regulatory Submission Specialist (18-months contract)
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Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products while taking a step further in your professional career.
Were looking for a Regulatory Specialist on a 18-month contract to cover maternity leave. This is a great opportunity for someone looking to gain hands-on experience in clinical research.
Office-based in Macquarie Park Sydney
Your role:
- Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities including Import and Export license applications.
- Communicate with regulatory authorities ethics committees project teams and vendors on regulatory-related matters.
- Review translations of essential documents subject to clinical trial submission.
- Track the regulatory project documentation flow.
- Review documents to greenlight IP release to sites.
- Manage safety reporting to authorities.
- Deliver regulatory training to project teams.
- Assist with feasibility research and business development requests.
Qualifications :
- University degree or an equivalent combination of education training and experience.
- 2-3 years experience with clinical trial submissions in Australia.
- Ability to learn plan and work in a dynamic team environment.
- Communication collaboration and problem-solving skills.
- Knowledge of ICH-GCP guidelines and local regulatory requirements.
- Experience in preparing and reviewing regulatory submission documents.
- Strong organizational skills and ability to manage multiple projects simultaneously.
- Excellent time management skills to meet tight deadlines.
- Ability to interpret and apply complex regulatory guidelines.
- Willingness to stay updated on changing regulations and industry trends.
Additional Information :
This is a great opportunity for you to further develop your skills widen your therapeutic area experience and become an expert in clinical research.
What youll get:
- Competitive salary
- We offer hybrid work arrangement - 2 days flexi and 3 days in office
- Access to a wide range of employee benefits
- Additional 5 days of wellness leave
- Development and learning opportunities
- Chance to make a real impact in a meaningful industry
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
