[Remote] Regulatory Operations Documentation Specialist (Contractor)
Note: The job is a remote job and is open to candidates in USA. Shionogi Inc. is a pharmaceutical company, and they are seeking a Regulatory Operations Documentation Specialist Contractor. This role focuses on formatting documents according to Shionogi standards and supporting the Regulatory Affairs team with compliance efforts and general assistance.
Responsibilities
ā¢ Assist in performing document formatting per Shionogi standards for submission related documentation
ā¢ Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files
ā¢ Provide support to the Regulatory Operations team
ā¢ Provide general assistance to the Regulatory Affairs department as needed
Skills
ā¢ High school degree required
ā¢ 2 years minimum experience in regulatory affairs within a pharmaceutical or biotechnology company
ā¢ Proficient in MS Office and Acrobat Adobe
ā¢ High level of attention to detail and accuracy in work
ā¢ Effective time management and organizational skills
ā¢ Strong written and verbal communication skills
ā¢ Able to work within a high-performance, collaborative team environment
ā¢ Associate degree preferred
ā¢ Experience with ISI Toolbox or equivalent software packages
ā¢ Experience with database systems; Veeva is a plus
Company Overview
ā¢ Since 1878, we have been committed to developing new treatments to improve patients' lives worldwide. It was founded in 2001, and is headquartered in Florham Park, New Jersey, US, with a workforce of 501-1000 employees. Its website is
Company H1B Sponsorship
ā¢ Shionogi Inc. (U.S.) has a track record of offering H1B sponsorships, with 5 in 2025, 2 in 2024, 6 in 2023, 5 in 2022, 2 in 2021, 7 in 2020. Please note that this does not guarantee sponsorship for this specific role.
Responsibilities
ā¢ Assist in performing document formatting per Shionogi standards for submission related documentation
ā¢ Assist in the remediation of PDF documents by bookmarking, hyperlinking and QCing to ensure compliant electronic files
ā¢ Provide support to the Regulatory Operations team
ā¢ Provide general assistance to the Regulatory Affairs department as needed
Skills
ā¢ High school degree required
ā¢ 2 years minimum experience in regulatory affairs within a pharmaceutical or biotechnology company
ā¢ Proficient in MS Office and Acrobat Adobe
ā¢ High level of attention to detail and accuracy in work
ā¢ Effective time management and organizational skills
ā¢ Strong written and verbal communication skills
ā¢ Able to work within a high-performance, collaborative team environment
ā¢ Associate degree preferred
ā¢ Experience with ISI Toolbox or equivalent software packages
ā¢ Experience with database systems; Veeva is a plus
Company Overview
ā¢ Since 1878, we have been committed to developing new treatments to improve patients' lives worldwide. It was founded in 2001, and is headquartered in Florham Park, New Jersey, US, with a workforce of 501-1000 employees. Its website is
Company H1B Sponsorship
ā¢ Shionogi Inc. (U.S.) has a track record of offering H1B sponsorships, with 5 in 2025, 2 in 2024, 6 in 2023, 5 in 2022, 2 in 2021, 7 in 2020. Please note that this does not guarantee sponsorship for this specific role.