Regulatory Coordinator Jobs

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Location:
Sweden, Stockholm

Category:
-

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

We are seeking a meticulous and organized Regulatory Coordinator to ensure that clinical trials and research activities comply with applicable regulations, guidelines, and internal standards. This role will focus on maintaining accurate documentation, supporting regulatory submissions, and coordinating compliance-related processes throughout the trial lifecycle.

Job Responsibility:

Support the preparation, review, and submission of regulatory documents to authorities and ethics committees
Ensure all trial documentation is accurate, complete, and maintained in compliance with Good Clinical Practice (GCP), regulatory requirements, and company policies
Coordinate the collection, organization, and archiving of essential trial documents
Track regulatory submission timelines and ensure deadlines are met
Assist in preparing trial master files and ensuring ongoing inspection readiness
Collaborate with clinical operations, quality assurance, and legal teams to resolve compliance issues
Maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards
Participate in audits and inspections, providing requested documentation and information
Monitor changes in regulatory requirements and communicate updates to relevant stakeholders
Provide administrative and logistical support for regulatory meetings and communications

Requirements:

Proven experience in regulatory affairs, clinical research, or a similar compliance-focused role
Solid understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials
Strong organizational skills with the ability to manage multiple projects and deadlines
Excellent attention to detail and accuracy in documentation
Proficiency in Microsoft Office Suite and familiarity with document management systems
Strong communication and collaboration skills
Fluency in English
Swedish language skills are an advantage

Nice to have:

Experience in coordinating regulatory submissions for multinational clinical trials
Knowledge of EU Clinical Trial Regulation (EU CTR) and other regional regulatory frameworks
Familiarity with electronic trial master file (eTMF) systems

What we offer:

A collaborative and quality-focused work environment
Opportunities for professional growth and training in regulatory affairs
Competitive salary and benefits package
The chance to contribute to clinical research projects with global impact

Additional Information:

Job Posted:
December 08, 2025

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Regulatory Coordinator