Regulatory Affairs Specialist

Join Pharmaxi as a Regulatory Affairs Specialist and support the preparation and management of regulatory documentation for clinical projects. This position is intended for people who work well with documents, formal requirements and communication with project teams and institutions involved in the clinical trial process.

Scope of responsibilities

preparing, completing and verifying regulatory documentation for clinical trials,
supporting submission processes and updates of project documentation,
cooperation with the Project Manager, CRA, CTA, sponsors and investigational sites,
monitoring document status, deadlines and required approvals,
participating in the preparation of responses to questions or documentation supplements,
ensuring documentation compliance with GCP requirements, procedures and applicable regulations,
supporting archiving and maintaining the completeness of clinical trial documentation.

Requirements

experience in regulatory affairs, clinical trials, medical documentation or a related area,
knowledge of GCP principles and basic regulatory requirements for clinical trials,
very good work organisation and accuracy in working with documents,
ability to analyse formal requirements and keep track of deadlines,
knowledge of English sufficient to work with project documentation,
responsibility, independence and communication skills.

Nice to have

experience in a CRO, pharmaceutical company, medical device company or IVD,
knowledge of processes related to clinical trial documentation in Poland or the EU,
experience working with documentation for medicinal products, medical devices or non-interventional studies,
education related to pharmacy, medicine, biotechnology, biology, medical law or similar fields.

What we offer

participation in clinical trial and clinical research projects,
opportunity to develop in regulatory affairs,
cooperation with an experienced project team,
work with documentation important for the proper conduct of clinical trials,
subject-matter support and clear work organisation.

How to apply

If you want to develop your career as a Regulatory Affairs Specialist in clinical trials, send us your CV. We will contact selected candidates to discuss their experience, the scope of the position and the next recruitment steps.