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Regulatory Affairs Specialist, Latam
hace 3 semanas
POSITION TITLE: Regulatory Affairs Specialist
REPORTS TO: Manager, Regulatory Affairs or Designee
BASIC FUNCTIONS:
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies) to the project team.
- Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
- Leads the preparation, submission and maintenance of regulatory filings with relevant health authorities
- Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
- Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
- Serve as IQVIA Biotech liaison with central IRBs.
- Perform other related duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
- Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
- Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
- Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
- Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
- Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
- Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
- Ability to read and synthesize technical material and to prepare clear and concise written documents.
- Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Ability to travel domestically and internationally 20%
- Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
- Requires Bachelor's degree with at least 3 years of related work experience, with 2 or more years in regulatory affairs, quality assurance and/or clinical research, or equivalent level of education, training and experience.
- Science degree preferred.
- Excellent analytical and communication skills, particularly writing skills, are essential.
- Must be familiar with and able to identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory bodies.
- Must be able to independently coordinate with interdisciplinary team members, manage timelines for and compile documents for pre-IND and IND submissions, with oversight from Regulatory Management.
- Demonstrated Clinical, Pre-clinical and or CMC knowledge for chemical or biologic products preferred.
- Demonstrated computer literacy is required.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
