Regulatory Operations Documentation Specialist
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Job Description
Support Regulatory Operations with electronic submission documentation. Focus on document formatting, quality control, and communication archiving with Health Authorities.
Responsibilities:
- 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.
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