Director, Global Regulatory Affairs Study Start Up

CTI Clinical Trial and Consulting Services; Santa Cruz de Tenerife; A distancia; EUR 100.000 - 120.000; Jornada completa

Descripción de la vacante

A global clinical trial organization is seeking a Director of Global Regulatory Affairs to manage RASSU activities and develop high-performance teams. Candidates should have over 15 years of experience, including project management in regulatory affairs. This role focuses on ensuring quality and efficiency in study start-up operations. Opportunities for professional growth, a hybrid work environment, and engagement in meaningful healthcare projects are available.

Servicios

Mentoring and leadership development

Hybrid work options

Community engagement initiatives

Formación

• 15+ years of experience in CRO or regulatory affairs.
• Experience managing complex multinational projects.
• Strong leadership and team development skills.

Responsabilidades

• Manage global RASSU activities to ensure quality and efficiency.
• Entrust and develop high-performance teams.
• Guide RASSU regional leaders in collaboration and growth.

Conocimientos

Managing large global teams

Regulatory Affairs

Project management

Educación

MS or PhD in a health-related field

Descripción del empleo

Director, Global Regulatory Affairs Study Start Up (level dependent on experience) - This position is open to candidates globally.

1. Manages and oversees global RASSU activities.
2. Provides guidance to RASSU regional leaders and fosters their collaboration and growth.
3. Ensures clinical study timelines, budgets, and quality measures are met and exceed accepted corporate standards.
4. Implements programs that ensure quality and efficiency in RASSU activities.
5. Attracts, develops, coaches, and retains high-performance team members, empowering them to increase their responsibilities, span of control, and performance.
6. Prepares and manages departmental budgets and implements cost-effective measures.
7. Ensures timely review and update of Global Standard Operating Procedures (GSOPs) in accordance with local guidelines and regulations.
8. Oversees and administers training for all RASSU staff.
9. Ensures staff review of GSOPs and addresses Quality Assurance (QA) suggestions and findings promptly.
10. Represents CTI in developing new business, assists with Clinical Operations presentations, reviews bid proposals, and facilitates out-of-scope activities.
11. Promotes departmental collaboration and harmonization on a global platform to streamline study start-up, improve processes, increase efficiencies, and leverage technology/software.
12. Leads organizational change and process harmonization within the global RASSU organization.
13. Manages departmental financial metrics to meet corporate objectives.

What You'll Bring :

1. At least 15 years of CRO or relevant experience, including managing large global teams and complex multinational aspects of Regulatory Affairs and study start-up activities.
2. MS or PhD degree in a health-related field or equivalent experience as determined by CTI Management and Human Resources.

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on treatments for chronically and critically ill patients. We support clinical research from drug concept to commercialization, headquartered in Greater Cincinnati, OH, with global operations collaborating with pharmaceutical, biotech, and medical device companies.

Why CTI?

1. Advance Your Career – We invest in your professional growth through mentoring, leadership development, and ongoing education.
2. Join an Award-Winning Team – Be part of a global team recognized for its culture that prioritizes people, with hybrid work options and community engagement through CTI Cares.
3. Make a Lasting Impact – Contribute to developing life-changing treatments for patients with chronic and critical illnesses, helping move medicine forward.

In light of recent hiring scams, if you're selected for the next phase, a team member will contact you from an @ctifacts.com email address. Please apply only through our website or verified LinkedIn page.

Please Note

1. We will never communicate via Microsoft Teams or text message.
2. We will never ask for your bank information during recruitment.