Regulatory Affairs Specialist

Pharmaxi LLC.; Warszawa; Hybrid; PLN 90,000 - 150,000; Full time

Job summary

Pharmaxi LLC in Warsaw seeks a Regulatory Affairs Specialist to support preparation and management of regulatory documentation for clinical projects. You will work with project teams and institutions involved in the clinical trial process.

The role emphasizes meticulous document handling, adherence to GCP requirements, submission support, and tracking deadlines. English suitable for project documentation and clear communication with partners is required.

Qualifications

• Experience in regulatory affairs, clinical trials, or medical documentation.
• Knowledge of GCP principles and basic regulatory requirements for clinical trials.
• Very good work organization and accuracy in handling documents.
• Ability to analyse formal requirements and monitor deadlines.
• Knowledge of English sufficient to work with project documentation.

Responsibilities

• Preparing, completing and verifying regulatory documentation for clinical trials.
• Supporting submission processes and updates of project documentation.
• Cooperating 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.

Skills

Regulatory affairs

GCP knowledge

Documentation accuracy

Deadline tracking

English proficiency

Education

Bachelor's in life sciences or related field

Education related to pharmacy/biomedicine

Job description

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 ...