Global Regulatory Submissions Lead

Moderna; Warszawa; Presencial; PLN 140 000 - 230 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Healthcare

Well-being resources

Family building benefits

Paid time off

Savings & investments

Location-specific perks

Resumo da oferta

Moderna Warsaw is seeking an experienced Regulatory Submissions Specialist to own planning, management and tracking of high-quality regulatory submissions across the global portfolio. You will partner with Regulatory Leads and cross-functional teams to orchestrate content from authoring through approval, publishing, QC and delivery to health authorities.

The role requires deep regulatory operations expertise, strong knowledge of eCTD/NeeS and lifecycle management, and the ability to lead

Qualificações

• 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 working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools.
• Extensive knowledge of North American/Global submission standards (FDA, Health Canada, EMA, ICH, eCTD) and dossier preparation.
• Knowledge of CDISC (ADaM, SEND, SDTM).
• Demonstrated ability to lead and/or collaborate with cross-functional groups (Regulatory, clinical, nonclinical).
• Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.
• MS PowerPoint skills and strong English proficiency.

Responsabilidades

• Manage development and maintenance of detailed submission content plans from authoring through QC and delivery.
• Act as a global submissions expert with knowledge of eCTD, NeeS, and lifecycle management variations.
• Provide regulatory operations expertise to cross-functional submission teams as a primary contact.
• Plan and prepare high-quality global submissions with internal or CRO partners for health authorities.
• Oversee planning, publishing, validation and timely submission of INDs, NDAs, and MAAs.
• Manage publishing vendor activities to support high-quality submission packages and timely delivery.
• Communicate project status, issues, and milestones to management and stakeholders.
• Maintain regulatory requirements alignment with Moderna processes and client requirements.
• Serve as subject matter expert for Moderna’s document management system.
• Coordinate distribution of submissions to health authorities and CROs within agreed timelines.
• Manage submission and product lifecycle information throughout the regulatory process.
• Lead special projects across Regulatory, Clinical, Nonclinical and other functions.
• Apply MS Word/PDf formatting best practices and use PowerPoint for stakeholder communication.
• Engage with Generative AI tools to enhance regulatory operations while maintaining compliance.

Conhecimentos

Regulatory ops

eCTD publishing

NeeS standards

Lifecycle management

Cross-functional

Submission planning

Documentation formatting

English proficiency

Formação académica

Bachelor's degree in science or systems tech

Ferramentas

eCTD publishing systems

EDMS

Publishing tools

MS Word

MS PowerPoint

Descrição da oferta de emprego

Moderna Warsaw is seeking an experienced Regulatory Submissions Specialist to own planning, management and tracking of high-quality regulatory submissions across the global portfolio. You will partner with Regulatory Leads and cross-functional teams to orchestrate content from authoring through approval, publishing, QC and delivery to health authorities.

The role requires deep regulatory operations expertise, strong knowledge of eCTD/NeeS and lifecycle management, and the ability to lead