Senior Regulatory Affairs, Study Start Up Specialist

Ctifacts; São Paulo; Híbrido; BRL 180 000 - 300 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work opportunities

Global exposure

Resumo da oferta

CTI Clinical Trial and Consulting Services seeks a Senior Regulatory Affairs Study Start Up Specialist to lead regulatory filings across multiple countries, with emphasis on study start-up activities and submission management. You will collaborate with sponsors, sites, and internal teams to ensure compliance with FDA/ICH/GCP guidelines while adapting ICFs to local requirements.

The role offers hybrid work opportunities in a dynamic CRO environment, with global exposure and ongoing professional

Qualificações

• Bachelor’s or associate degree in an allied health field or equivalent experience.
• 5–8 years of pharmaceutical or CRO regulatory experience.
• Experience with Clinical Trials submissions in Latam countries.
• Strong knowledge of FDA, GCP, ICH regulations and guidelines.
• Excellent written and verbal English communication.

Responsabilidades

• Advise project teams on regulatory requirements for clinical studies.
• Perform compliance assessments per country requirements; flag findings.
• Review and adapt study documents per country/site requirements.
• Prepare/oversee IRB/EC/CA submissions and regulatory bodies’ submissions.
• QC and quality check study documentation before submissions.
• Adapt informed consent forms per IRB requests and local requirements.
• Interact with sponsors, sites, PMs and CRO staff to resolve documentation issues.
• Provide periodic regulatory status reports and attend project meetings.

Conhecimentos

Regulatory submissions

GCP/ICH knowledge

Cross-functional collaboration

Documentation quality

Communication skills

Formação académica

Bachelor’s degree in allied health or equivalent

Associates degree in allied health

Ferramentas

Regulatory software

Descrição da oferta de emprego

Senior Regulatory Affairs, Study Start Up Specialist

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

What You'll Do

• Assist/Advise project teams on all regulatory requirements for clinical studies
• Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings
• Review and adapt study specific documents according each country and site requirements
• Perform / oversee IRB/EC/CA and/ or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirements
• Receive and process study documentation from sites, check content and quality as well as completeness
• Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review
• Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements and /or perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements
• Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracy
• Preparation and/or quality check and filing of site adapted ICF according to local requirements
• Prepare or/and QC Clinical Trial Application forms (e.g. CTA, XML), where applicable
• Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
• Respond to Deficiency Letters from IRB/IEC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements
• Compiling and/or assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
• Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed
• Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
• Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
• Prepare for Sponsor or Agency audits and inspections
• QC and QA of various study related Regulatory documents and reports
• Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
• Attend internal and external study meetings and regulatory status reports for each site and country during study meetings
• Represent the Regulatory Department in capabilities and bid defense presentations
• Train and mentor less experienced Regulatory staff and other CTI functional department staff regarding regulatory work
• Develop relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs

What You'll Bring

• Associates or bachelor’s degree in allied health field such as nursing, pharmacy, or health science or the equivalent relevant experience
• A minimum of 5 - 8 years relevant pharmaceutical or CRO Regulatory experience
• Experience in Clinical Trials Submissions in several Latam countries
• Strong working knowledge and understading of FDA, Good Practice (GCP)/International Council for Harmonisation (ICH) regulations and guidelines
• Ongoing willingness to learn
• Detail oriented
• Ability to collaborate well in a team environment
• Ability to maintain confidentiality
• Proficient in use of computer and software systems
• Excellent verbal and written communication skills
• Fluent in oral and written English
• Ability to provide superior level of customer service
• Ability to develop, prioritize, organize, and manage multiple tasks
• Strong decision making and creative problem-solving skills
• Strong understanding and application of principles, concepts, practices, and standards of CRO industry
• Strong working knowledge and understanding of national and international regulations and guidelines, Good Clinical Practice (GCP) and International Council for Harmonization (ICH)

Why 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.