Regulatory Submissions Specialist — FDA/eCTD Expert

Artech Information System LLC; Cambridge (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading IT staffing company is seeking a skilled professional to join their Regulatory Affairs Operations team. The candidate will be responsible for publishing and maintaining regulatory filings while ensuring compliance with all necessary standards. Ideal candidates will have at least four years of submission publishing experience and a relevant bachelor's degree. This role offers a challenging environment with tight deadlines and responsibilities in a highly regulated field.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• At least four years of submission publishing experience.
• Understanding of regulatory affairs and submission processes.

Responsibilities

• Publish and submit regulatory filings.
• Ensure compliance standards for information delivery.
• Support planning and development of submissions.
• Control submission workflow to ensure quality.
• Dispatch submissions through the FDA Gateway.

Skills

MS Office proficiency

Adobe Professional skills

Knowledge of ICH and FDA regulations

Strong analytical skills

Detail-oriented

Ability to multi-task

Education

Bachelor's degree in regulatory affairs or related fields

Tools

sCubed

eCTD Manager

Document Management Systems

Job description

A leading IT staffing company is seeking a skilled professional to join their Regulatory Affairs Operations team. The candidate will be responsible for publishing and maintaining regulatory filings while ensuring compliance with all necessary standards. Ideal candidates will have at least four years of submission publishing experience and a relevant bachelor's degree. This role offers a challenging environment with tight deadlines and responsibilities in a highly regulated field.