Junior Regulatory Affairs Scientist – 12 months contract
We are now looking for a PhD graduate with interest in regulatory affairs and biologics to join a dynamic team where further scientific development is offered.
* Writing and reviewing scientific documents for Health Authority submission,
* Prepare responses to health authority questions during development, registration and product lifecycle.
* Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
* Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
* Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
* Establish and maintain sound working relationships with partners and customers.
* Advanced Degree in Science (Pharmacy, Biochemistry, Biotechnology) or equivalent.
* Prior experience with regulatory submission dossier or experience in drug/biopharmaceuticals
* Working knowledge of biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process
* Knowledge/experience of regulations and guidelines for regulatory submissions
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.