Regulatory Affairs Associate

To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

- Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies).
- Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
- Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
- 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.
- Familiarity with or ability to assist 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
- Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

- Requires Bachelor's degree with at least 2 year of related work experience, science degree preferred or equivalent level of education and work experience.
- At least one year of work experience in areas relevant to regulatory affairs, quality assurance, and clinical research.
- Excellent analytical and communication skills, particularly writing skills, are essential.
- Demonstrated computer literacy is required.
- Ability to travel a minimum of 20% both domestically and internationally is required.

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