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Job summary
A leading IT staffing company is seeking a Regulatory Affairs Operations professional to publish, submit, and maintain regulatory filings. The role requires at least four years of submission publishing experience and a bachelor's degree in a related field. Responsibilities include supporting Global Regulatory Leads, ensuring compliance with standards, and effectively coordinating publishing tasks. Candidates should be detail-oriented and proficient in relevant software, assertive in a fast-paced environment, and possess strong analytical skills.
Qualifications
At least four years of submission publishing experience.
Detail oriented with strong analytical and decision-making skills.
Responsibilities
Publish, submit, and maintain regulatory filings.
Support Global Regulatory Leads in submission planning and development.
Ensure compliance with internal and external standards.
Skills
Proficient in MS Office
Adobe Professional
Publishing Software (sCubed and/or eCTD Manager)
Validation Tools
Document Management Systems
Education
Bachelor's degree in regulatory affairs or related field
Job description
A leading IT staffing company is seeking a Regulatory Affairs Operations professional to publish, submit, and maintain regulatory filings. The role requires at least four years of submission publishing experience and a bachelor's degree in a related field. Responsibilities include supporting Global Regulatory Leads, ensuring compliance with standards, and effectively coordinating publishing tasks. Candidates should be detail-oriented and proficient in relevant software, assertive in a fast-paced environment, and possess strong analytical skills.