Regulatory Operations Documentation Specialist

Overview

This role supports the Regulatory Operations team by preparing submission-related documentation for electronic submission to Health Authorities. Responsibilities include document formatting, remediation, quality control (QC) of submission materials, archiving correspondence with Health Authorities, and managing documents stored at or retrieved from offsite facilities. Experience with Microsoft Word, Adobe Acrobat, and Veeva RIM is preferred.

Responsibilities

• Support document formatting and quality control in alignment with regulatory standards for submission materials.
• Assist in remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
• Ensure all communications with Health Authorities are properly archived within the company’s system and comply with applicable regulatory guidelines.
• Assist with archiving and retrieval of documents from offsite storage facilities.
• Provide ongoing support to the Regulatory Operations team.

Minimum Job Requirements

• High school diploma required; Associate’s degree preferred.
• Pharmaceutical industry experience is a plus but not required.
• Proficient in Microsoft Office and Adobe Acrobat.
• Experience with ISI Toolbox or equivalent software.
• Experience with database systems; Veeva experience is a plus.
• High attention to detail and accuracy.
• Effective time management and organizational skills.
• Strong written and verbal communication skills.
• Ability to work collaboratively within a high-performance team environment.

Compensation & Benefits

• Hourly rate: $40 - $57, determined by job-related skills, experience, and relevant education or training.
• This range does not include comprehensive benefits, bonuses, allowances, or additional compensation that may be associated with the role.

Equal Employment Opportunity

The employer is an equal opportunity organization supporting individuals with disabilities and veterans. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, veteran status, or any other characteristic protected by law. Affirmative action is undertaken to recruit a diverse pool of protected veterans and individuals with disabilities and to ensure non-discriminatory employment practices.

Reasonable accommodations are available for qualified individuals with disabilities or disabled veterans who are unable or limited in their ability to apply for vacancies due to disability.