Principal Technical Editor, Regulatory Submissions Lead

Certara; Kraków; On-site; PLN 120,000 - 180,000; Full time

Job summary

Certara in Kraków seeks a Principal Technical Editor to lead complex QC and document formatting projects within Regulatory Services. You will serve as SME for deliverable quality, mentor teams, manage regulatory submissions, and influence process improvements across the organization.

The role requires 7+ years in pharma/science editing or regulatory operations, a bachelor’s degree, strong MS Office and Adobe skills, and hands-on knowledge of US/CA/EU eCTD submission and redaction.

Qualifications

• Bachelor’s degree in a scientific discipline, English, or related field.
• At least 7 years of related experience in pharmaceuticals or life sciences editing and regulatory operations.
• Editor in the Life Sciences certification is desired but not required.
• Strong computer skills with MS Office and Adobe products.
• Knowledge of US/CA/EU eCTD submission and redaction requirements.
• Proven success leading teams to maintain project alignment.

Responsibilities

• Leads large QC and document-level formatting projects.
• Mentors QC staff and coordinates cross-functional teams.
• Manages regulatory submissions and ensures guideline compliance.
• Develops processes to improve efficiency, quality, and productivity.
• Provides technical guidance and solution-driven responses to internal/external teams.
• Collaborates with business partners and leaders to drive alignment.

Skills

Team leadership

Regulatory submissions

Document editing

Project management

eCTD knowledge

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office

Adobe Acrobat

Job description

Certara in Kraków seeks a Principal Technical Editor to lead complex QC and document formatting projects within Regulatory Services. You will serve as SME for deliverable quality, mentor teams, manage regulatory submissions, and influence process improvements across the organization.

The role requires 7+ years in pharma/science editing or regulatory operations, a bachelor’s degree, strong MS Office and Adobe skills, and hands-on knowledge of US/CA/EU eCTD submission and redaction.