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

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
  - level and junior team members
• Building a training curriculum for
  - 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
  - specific and
  - 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 e
  TMF systems
• Supporting preparation for EMA, MHRA, and other EU regulatory body audits and inspections
• Ensuring staff documentation is
  - 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
- life balance, and provides opportunities for giving back to the community.