European Clinical Trials Regulatory Start-Up Lead

Consulting, Inc.; España; On-site; PHP 900,000 - 1,200,000; Full time

Job summary

Consulting, Inc. is hiring for a regulatory role in Romblon, España. The candidate will assist project teams with regulatory requirements for clinical studies and will compile necessary documentation while ensuring compliance with local regulations.

Ideal candidates should have a degree in allied health and 3-5 years of experience in regulatory roles. Proficiency in European clinical trials and CTIS is required. Strong communication and project management skills are essential.

Qualifications

• A minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experience.
• Expertise in leading regulatory start-up strategy for European clinical trials applications.
• Hands-on experience in coordinating and preparing regulatory applications.

Responsibilities

• Assist/Advise project teams on regulatory requirements for clinical studies.
• Perform compliance assessments and notify Project Managers of findings.
• Compile Regulatory documentation according to CTI SOPs and local requirements.

Skills

Regulatory compliance

Clinical trials documentation

Quality Control (QC)

Project management

Education

Associate’s or Bachelor’s degree in allied health

Tools

CTIS

Job description

Consulting, Inc. is hiring for a regulatory role in Romblon, España. The candidate will assist project teams with regulatory requirements for clinical studies and will compile necessary documentation while ensuring compliance with local regulations.

Ideal candidates should have a degree in allied health and 3-5 years of experience in regulatory roles. Proficiency in European clinical trials and CTIS is required. Strong communication and project management skills are essential.