Regulatory Affairs, Study Start Up Specialist II

CTI; Ciudad de México; Presencial; USD 30,000 - 50,000; Jornada completa

Descripción de la vacante

A leading clinical contract research organization is seeking a Regulatory Affairs, Study Start Up Specialist II. This role involves advising project teams on regulatory requirements, managing submissions, and ensuring compliance with local regulations. The ideal candidate will have a degree in nursing, pharmacy, or health science, along with 3-5 years of regulatory experience in clinical trials. Join a dynamic team committed to advancing life-changing treatments.

Servicios

Career Advancement

Hybrid work options

Community engagement through CTI Cares

Formación

• 3-5 years of regulatory experience in pharmaceuticals, sites, or CROs.
• Strong knowledge of FDA, GCP, ICH regulations and guidelines.

Responsabilidades

• Assist and advise project teams on all regulatory requirements for clinical studies.
• Handle IRB/EC submissions on behalf of sponsors and/or sites.
• Compile regulatory documentation following SOPs and perform QC before submission.

Conocimientos

Communication

Organization

Confidentiality

Educación

Associate or Bachelor’s degree in nursing

Bachelor’s degree in pharmacy

Bachelor’s degree in health science

Herramientas

Computer systems

Descripción del empleo

Regulatory Affairs, Study Start Up Specialist II

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patients. We support clinical research throughout the development lifecycle, from drug concept to commercialization. Headquartered in Greater Cincinnati, OH, with global operations collaborating with pharmaceutical, biotechnology, and medical device companies. For more information, visit www.ctifacts.com.

What You’ll Do

• Assist and advise project teams on all regulatory requirements for clinical studies.
• Perform compliance assessments based on country-specific requirements, document findings, and notify Project Managers.
• Review and adapt study-specific documents according to country and site requirements.
• Handle IRB/EC (CA) and other Regulatory Bodies submissions on behalf of sponsors and/or sites, in accordance with country requirements.
• Receive, process, and review study documentation for content, quality, and completeness.
• Coordinate with site personnel, CPCs, CRAs, and PMs to correct, clarify, or resolve documentation issues found during reviews.
• Compile regulatory documentation following SOPs and perform QC before submission.
• Assist with and adapt Informed Consent Forms (ICF) per IRB/IEC requests.
• Prepare, review, and file site-adapted ICFs per local requirements.
• Prepare and QC Clinical Trial Application forms (e.g., CTA, XML).
• Communicate with sponsors, sharing regulatory documentation and submission packages as needed.
• Respond to deficiency letters from regulatory bodies in collaboration with sponsors and study teams.
• Assess the completeness of regulatory packages for drug release.
• Provide periodic status reports to project teams and attend project meetings.
• Ensure correct naming, uploading, and processing of study documentation in TMF systems.
• Review, reconcile, close, and archive study documentation.
• Assist in preparing for audits and inspections.
• Support QC and QA activities of regulatory documents and reports.
• Oversee translation of regulatory documents if required.
• Participate in internal and external study meetings and report on regulatory status.
• Manage site budgets and contracts depending on regions.

Required Education/Experience:

• Associate or Bachelor’s degree in nursing, pharmacy, health science, or relevant experience.
• 3-5 years of regulatory experience in pharmaceuticals, sites, or CROs.
• Experience with clinical trial submissions in LATAM countries.
• Strong knowledge of FDA, GCP, ICH regulations and guidelines.
• Excellent communication skills, both verbal and written.
• Fluent in English.
• Ability to manage multiple tasks with organization and priority.
• Proficient in computer systems and software.
• Ability to maintain confidentiality and demonstrate industry principles and standards.

Why CTI?

• Career Advancement – We invest in your professional growth through mentoring, leadership courses, and training, encouraging ongoing education.
• Join an Award-Winning Team – Be part of a global team recognized for a culture that values people, with hybrid work options and community engagement through CTI Cares.
• Make a Difference – Contribute to developing life-changing treatments for patients and advancing medicine.

Important Note

Due to recent hiring scams, if selected for the next hiring phase, a team member will contact you from an @ctifacts.com email address. Apply only through our website or verified LinkedIn page.

• We will not contact you via Microsoft Teams or SMS.
• We will never request your bank details during recruitment.