Senior Regulatory Documentation Specialist – eCTD & Veeva

Avetix Bio; Summit (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Avetix Bio is seeking a Specialist III, Regulatory Documentation to lead and guide the management and publishing of regulatory documents ensuring conformance with Health Authority requirements. The role supports staff in document management and coordinates eCTD modules.

The ideal candidate has a Bachelor’s degree in life sciences or technical discipline and 5+ years of regulatory operations experience, with expert knowledge of Health Authority procedures and Veeva Vault (RIM).

Qualifications

• Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission.
• Strong knowledge of Electronic Document Management Systems.
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.

Responsibilities

• Create and maintain electronic project folders for projects.
• Maintain Veeva RIM by uploading submission materials and Health Authority correspondence.
• Serve as advisor to internal departments in preparation and submission of regulatory documentation.
• Format and publish documents for regulatory submissions and reports.
• Prepare templates and document shells for inclusion of text and data.
• Train Regulatory Documentation Specialists on SOPs and processes.
• Collaborate on software upgrades and continuous improvement of documentation systems.

Skills

Regulatory knowledge

Veeva Vault

Documentation accuracy

Education

Bachelor’s degree in life sciences or technical discipline

High school diploma with 9+ years regulatory operations experience

Tools

Veeva RIM

Job description

Avetix Bio is seeking a Specialist III, Regulatory Documentation to lead and guide the management and publishing of regulatory documents ensuring conformance with Health Authority requirements. The role supports staff in document management and coordinates eCTD modules.

The ideal candidate has a Bachelor’s degree in life sciences or technical discipline and 5+ years of regulatory operations experience, with expert knowledge of Health Authority procedures and Veeva Vault (RIM).