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Job Description

Manager RASSU (Regulatory Affairs and Study Start Up) - Global Dedicated Role (EU Region)

This is a senior role that requires experience in regulatory affairs, clinical trial management, and team leadership.

- Responsibilities include:

- Direct line management of team members, including interviewing, onboarding, performance management, and goal setting
- Creating and providing training to entry-level and junior team members
- Building a training curriculum for entry-level staff
- Regulatory knowledge of clinical trial requirements and processes, including CTR (EU Regulation 536/2014) and MHRA
- Submitting medical devices and GMOs to national competent authorities and ethics committees
- Understanding study document adaptation to meet country-specific and site-specific requirements
- Quality control and compliance with SOPs, ICH/GCP, and GDPR standards
- Cross-functional communication and collaboration internally and externally
- Managing and overseeing study timelines from startup to closure
- Project coordination and regulatory tracking, including maintaining regulatory document tracking and eTMF systems
- Supporting preparation for EMA, MHRA, and other EU regulatory body audits and inspections
- Ensuring staff documentation is audit-ready, properly archived, and aligned with regulatory expectations

Requirements include:

- Bachelor’s degree in an allied health field or equivalent relevant experience
- A minimum of 10-12 years of relevant pharmaceutical, site, or CRO regulatory experience
- Fluency in English

About the company:

CTI Clinical Trial and Consulting Services is a global company that invests in employee growth and development, offers a structured mentoring program, and encourages ongoing education.

The company culture prioritizes people, supports work-life balance, and provides opportunities for giving back to the community.

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