about 1 year ago
Would you like the opportunity to join a major CRO?
I am currently partnering with a global CRO who are projecting to grow by 20% this year and will be looking to increase their Regulatory Affairs department by adding a Regulatory Submissions Coordinator.
You will work on exciting projects across all major therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
Some of your responsibilities in this role will be:
* Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Germany, Austria and Switzerland
* Prepare and submit responses to queries and amendments to clinical trial applications
* Ensure submissions comply with applicable regulations and guidance documents
* Advise sponsors on changing regulations and compliance requirements
* Track submissions and ensure timely filing of documents
* Collection of essential documents and preparation essential documents packages for drug release.
You will need the following expertise:
* Bachelor's degree in life sciences
* Excellent organisation and communication skills
* Knowledge of Microsoft Office
* Hands-on experience preparing, reviewing, and submitting regulatory documentation
* At least one year of work experience as a Regulatory Submissions Coordinator
* Fluency in English and German language
Package / Benefits:
* Competitive Salary
* Annual Performance Related bonus
* Structured Training
* Career progression
* Flexible Work/Life balance
* Relocation support within region available
If this opportunity is of interest to you then please get in touch!