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

(Please submit your CV in English)

What You'll Do

Core Competencies:

• Line Management
  • Experienced with direct line management including interviewing, onboarding, performance management, timecard/vacation approval, goal setting, resource management
• Training/Mentoring
  • Skilled with creating and providing training to
    - level and junior team members, within the clinical research industry
  • Ability to build a training curriculum for
    - level staff for a growing team
• Regulatory Knowledge
  • Knowledge of clinical trial regulatory requirements and processes, including CTR (EU Regulation 536/2014), MHRA, and other national competent authorities.
  • Knowledge submitting medical device and GMO to national competent authorities and ethics committees.
• Clinical Trial Documentation & Quality Assurance
  • Understanding study document adaptation (e. g. , ICFs, CTAs) to meet
    - specific and
    - specific requirements.
  • Strong focus on quality control (QC) and compliance with SOPs, ICH/GCP and GDPR standards.
• Cross-Functional Communication
  • Effective communicator focusing on collaboration internally and externally
  • Ability to manage and oversee study timelines from study startup through study closure
• Project Coordination & Regulatory Tracking
  • Proficient in maintaining regulatory document tracking, e
    TMF systems, and study
    - up modules to ensure timely submissions and approvals.
  • Regularly provides status updates and coordinates with other functional teams responsible for study start up activities in expediting site start up processes.
• Audit & Inspection Preparedness
  • Support preparation for EMA, MHRA, and other EU regulatory body audits and inspections, as needed.
  • Ensure staff documentation is
    - ready, properly archived, and aligned with regulatory expectations.
• Multilingual & Multinational Adaptability
  • Familiarity with cultural nuances and local ethics requirements across regions.
  • Fluent in spoken and written English.
• Attention to Detail & Process Orientation
  • Demonstrates meticulous attention to document accuracy, version control, and naming conventions.
  • Excellent organizational skills to manage complex global regulatory workflows across regions.

What You'll Bring

• Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
• A minimum of 10-12 years of relevant pharmaceutical, site, or CRO Regulatory experience
• Fluency in English

About CTI

• Advance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.
• Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its
  - winning culture that prioritizes people. We support your
  - life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing
  - changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified Linked
In page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process