Regulatory Coordinator โ Focuses on Trial Compliance and Documentation
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.
Responsibilities
- 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.
Preferred Qualifications
- 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.
About: English Jobs Sweden
EnglishJobs.se specializes in recruiting international talent for Swedish companies. Since 2009 we have have helped over 8000 professionals connect with traditional companies such as as Ericsson, Skanska, ABB, Volvo and SAAB as well Swedish startups such as Spotify, TrueCaller, Klarna and Skype. We welcome talent with a multicultural background and knowledge of local cultures, languages and business markets. Industries we cover: Tech, Marketing & Communications, Events, Media, Retail, Travel, Hospitality, Finance, Gaming, Healthcare, Consulting
