Global Regulatory Submissions Manager

Moderna Therapeutics; Warszawa; Hybrid; PLN 180,000 - 320,000; Full time

Benefits offered by this job

Competitive healthcare

AI-assisted tools exploration

In-office collaboration (70/30)

Job summary

Moderna Therapeutics seeks a Submission Manager in Warsaw to own planning, management and tracking of regulatory submissions across a global portfolio. You will work with Regulatory Leads and cross-functional teams to author, publish, QA and deliver content to health authorities.

You will ensure expertise in eCTD, NeeS, lifecycle management, and regional differences while exploring Generative AI tools to enhance regulatory operations with high quality and compliance.

Qualifications

• Bachelor's degree in a scientific discipline or systems technology or equivalent.
• 5–8 years of pharmaceutical experience in a regulated life science environment.
• Advanced knowledge of eCTD publishing systems and EDMS.
• North American/Global submission standards (FDA, Health Canada, EMA, ICH) knowledge.
• Ability to lead cross-functional groups (Regulatory, clinical, nonclinical).
• Strong MS Word/PDF formatting and troubleshooting skills.
• Proficiency in English for global collaboration.

Responsibilities

• Develop and maintain submission content plans covering all source documents and data.
• Serve as global submissions expert on eCTD and NeeS formats and lifecycle management.
• Provide regulatory operations expertise to cross-functional submission teams.
• Plan and prepare high-quality global submissions with in-house or CRO partners.
• Oversee publishing and timely submission of INDs, NDAs and MAAs to health authorities.
• Manage publishing vendor activities for submission packages.
• Communicate project status, issues and milestones to management and stakeholders.
• Maintain alignment with regulatory requirements and Moderna document management standards.
• Coordinate distribution of submissions to health authorities and CROs.

Skills

eCTD publishing

EDMS technology

Regulatory submissions

Cross-functional collaboration

MS Word formatting

MS PowerPoint

English proficiency

Education

Bachelor's degree in science or systems technology

Tools

MS Word

PDF Professional

PowerPoint

Job description

Moderna Therapeutics seeks a Submission Manager in Warsaw to own planning, management and tracking of regulatory submissions across a global portfolio. You will work with Regulatory Leads and cross-functional teams to author, publish, QA and deliver content to health authorities.

You will ensure expertise in eCTD, NeeS, lifecycle management, and regional differences while exploring Generative AI tools to enhance regulatory operations with high quality and compliance.