Regulatory Operations Documentation Specialist

Support document formatting and QC in alignment with Shionogi standards for submission-related materials.

Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory‑compliant electronic files.

Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.

Assist the archiving and retrieval of documents from offsite storage facilities.

Provide ongoing support to the Regulatory Operations team.

Requirements

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