Regulatory Affairs Specialist
4 semanas atrás
Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico. The successful candidate will be responsible for assisting project teams with regulatory requirements for clinical studies, performing compliance assessments, and reviewing study specific documents.
Key Responsibilities
- Assist project teams with regulatory requirements for clinical studies
- Perform compliance assessments and document any activity discovered
- Review and adapt study specific documents according to country and site requirements
- Perform IRB/EC and/or other Regulatory Bodies submissions on behalf of sponsors and sites
- Receive and process study documentation from sites, check content and quality, and 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, 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
- Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site level
- Assist in preparation, quality check, and filing of site adapted ICF according to local requirements
- Prepare 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 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
- Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
- Assist with preparation for Sponsor or Agency audits and inspections
- Assist with 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
- Sites budgets and Sites contracts management, depending on Countries/Regions
Requirements
- Associate or Bachelor's degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
- At least 3 years of relevant pharmaceutical, site, or CRO Regulatory experience
- Experience in Clinical Trials Submissions in several LATAM countries
- Strong working knowledge and understanding of FDA, Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) regulations and guidelines
Competencies
- Ability to work well in a team environment
- Ongoing willingness to learn
- Detail oriented
- Excellent verbal and written communication skills
- Fluent in oral and written English is a must, good Spanish language skills are also needed
- Ability to develop, prioritize, organize, and manage multiple tasks
- Ability to provide superior level of customer service
- Proficient in use of computer and software systems
- Ability to maintain confidentiality
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