Regulatory Submissions Publishing Lead

Artech Information System LLC; Bridgewater (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading IT staffing company is seeking a highly skilled individual for the Regulatory Affairs Operations role. The position focuses on publishing and maintaining regulatory filings while adhering to compliance and quality standards. Ideal candidates will possess a Bachelor's degree and significant experience in submission publishing along with strong analytical and interpersonal skills. This opportunity offers the chance to work in a fast-paced environment where attention to detail is crucial.

Qualifications

• Must be detail-oriented and articulate.
• Demonstrates flexibility in dealing with change.
• Knowledge of ICH and FDA regulations.

Responsibilities

• Publish and maintain regulatory filings.
• Ensure compliance standards are met.
• Control submission component receipt and workflow.

Skills

MS Office proficiency

Adobe Professional

Publishing Software (sCubed/eCTD Manager)

Validation Tools

Document Management Systems

Detail-oriented

Analytical skills

Interpersonal skills

Understanding of regulatory affairs

Education

Bachelor's degree in regulatory affairs or related field

4 years submission publishing experience

Job description

A leading IT staffing company is seeking a highly skilled individual for the Regulatory Affairs Operations role. The position focuses on publishing and maintaining regulatory filings while adhering to compliance and quality standards. Ideal candidates will possess a Bachelor's degree and significant experience in submission publishing along with strong analytical and interpersonal skills. This opportunity offers the chance to work in a fast-paced environment where attention to detail is crucial.