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

Phiture; Lisboa; Híbrido; EUR 60 000 - 80 000; Tempo integral

Resumo da oferta

A clinical research organization located in Lisbon seeks a Regulatory Manager with over 10 years of experience in the pharmaceutical industry. The role requires strong leadership in managing line staff, handling regulatory documentation, and adhering to compliance standards. The candidate must be fluent in English and possess a relevant degree in a health-related field. The organization offers a supportive environment for professional growth, including mentoring and hybrid work options.

Serviços

Structured mentoring program

Leadership development courses

Opportunities for ongoing education

Work-life balance initiatives

Qualificações

• A minimum of 10-12 years of relevant pharmaceutical, site, or CRO Regulatory experience.
• Fluency in spoken and written English.

Responsabilidades

• Manage and oversee study timelines from startup through closure.
• Coordinate with functional teams for study submissions and approvals.
• Support preparation for regulatory audits and inspections.

Conhecimentos

Line Management

Training/Mentoring

Regulatory Knowledge

Clinical Trial Documentation & Quality Assurance

Cross-Functional Communication

Project Coordination & Regulatory Tracking

Audit & Inspection Preparedness

Multilingual & Multinational Adaptability

Attention to Detail & Process Orientation

Formação académica

Bachelor’s degree in allied health field

Descrição da oferta de emprego

(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 entry-level and junior team members, within the clinical research industry
  • Ability to build a training curriculum for entry-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 country-specific and site-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, eTMF systems, and study start-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 audit-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 award-winning culture that prioritizes people. We support your work-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 life-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 LinkedIn 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