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Regulatory Affairs Specialist, LATAM

hace 2 meses

San Cristóbal de las Casas, Chiapas, México Iqvia A tiempo completo
Regulatory Affairs Specialist, LATAM

**Job Summary**

We are seeking a highly skilled Regulatory Affairs Specialist to join our team in LATAM. The successful candidate will be responsible for providing regulatory information, guidance, training, support, and strategic planning to assigned clinical research projects.

**Key Responsibilities**

  • Assist in assuming primary or secondary regulatory responsibility for assigned clinical research projects.
  • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and organizations.
  • Lead the preparation, submission, and maintenance of regulatory filings with relevant health authorities.
  • Ensure the compilation and maintenance of pertinent documentation required for regulatory compliance.
  • Serve as a member of groups, teams, or committees related to regulatory affairs, quality assurance, or other designated IQVIA Biotech activities.

**Requirements**

  • 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 methods of filing and tracking.
  • 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.

**Working Conditions**

  • Ability to travel domestically and internationally (20% of the time).

**Education and Experience**

  • 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.

**Language**

English (US)