Reg Affairs Assistant

Position Overview

• Location Type: Office
• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Salary: Not provided

Provides administrative support to the department, including management and maintenance of regulatory documents, tools, and websites.

Requirements

• High school / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
• Prior experience in the pharmaceutical/CRO industry is preferred.
• Additional Required Skillsets:
  • Advanced Level Word Formatting Skills (Clinical and Non-Clinical Regulatory Documents)
  • Veeva experience (document upload)

Responsibilities

• Provides administrative support to the department including travel arrangements, coordination of expenses, meeting planning and preparation of presentations.
• Manages the document archiving and retrieval process, including maintaining archive areas for:
  • Departmental processes/mapping
  • Department-level training and job aids
  • Regulatory metrics and business development documentation.
• Assists in the management on SOPs/WPDs.
• Assists in revision and maintenance of department webpage, as needed.
• Assist with maintenance of utilization/resourcing tools.
• Assist with archiving of documents and submissions.

Qualifications

• Education and Experience:

  • High school / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
  • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• Knowledge, Skills, and Abilities:

  • Good organizational and planning skills to effectively manage shifting priorities.
  • Capable of working effectively on a team and/or independently with minimal supervision.
  • Good electronic document production skills.
  • Good proficiency in several computer applications including Microsoft Office software.
  • Good attention to detail and quality of documentation.
  • Good interpersonal skills with the ability to interact with customers.
  • Solid verbal and written communication skills.
  • Capable of multitasking and managing multiple projects.

Management Role

• No management responsibility

Working Conditions and Environment

• Work is performed in an office environment.

Application Instructions

• Not provided