Manager, Regulatory Operations

Job description

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.

As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage.

This hub provides critical functions, meeting the growing demand of Moderna’s global business operations.

We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.

As a Regulatory Operations Submission Manager, you will serve as the primary operational driver of global regulatory submissions, collaborating closely with Regulatory Leads and project teams.

Your expertise in electronic submissions (eCTD, NeeS) and lifecycle planning will ensure the timely and compliant delivery of high-quality submissions to global health authorities.

You will be responsible for managing submission content plans, overseeing third-party publishing vendors, and acting as a subject matter expert in Moderna’s document management systems.

In this pivotal role, you will enable Moderna’s regulatory strategy execution across multiple programs and contribute to bringing transformative mRNA medicines to patients worldwide.

This individual contributor position is based in Warsaw and plays a critical part in Moderna’s global regulatory infrastructure.

Here’s What You’ll Do:

Your key responsibilities will be:

• Manage the end-to-end development and maintenance of regulatory submission content plans, including tracking documents from authoring to publishing, QC, and final delivery.

• Serve as the global submissions expert on project teams, guiding best practices and compliance standards across global regions.

• Communicate project status, timelines, risks, and deliverables effectively to internal teams and key stakeholders.

• Provide operational oversight for the planning, preparation, publishing, and validation of major regulatory submissions, including BLAs, MAAs, amendments, updates, and variations.

• Coordinate submission delivery timelines with internal and external stakeholders including CROs and Health Authorities.

Your responsibilities will also include:

• Manage activities of publishing vendors to ensure submission packages are accurate, complete, and delivered on time.

• Maintain deep technical knowledge of evolving global regulatory requirements and align Moderna practices accordingly.

• Act as subject matter expert for Moderna’s document management system, supporting efficient document workflows and compliance.

• Oversee the distribution of submission dossiers to all relevant parties and manage lifecycle data for both submissions and products.

• Lead special regulatory operations projects as needed, bringing operational excellence to strategic initiatives.

The key Moderna Mindsets you’ll need to succeed in the role:

• “We digitize everywhere possible using the power of code to maximize our impact on patients.”
  In this role, you'll be immersed in complex digital document management systems, submission tracking platforms, and automated publishing solutions—requiring a digital-first mindset to improve operational efficiency and compliance.

• “We behave like owners.
  
  The solutions we’re building go beyond any job description.”
  You will be the cornerstone of global submission planning and execution, taking full ownership of submission deliverables and timelines that directly impact Moderna’s ability to deliver on its regulatory commitments worldwide.
  
  Your proactive leadership will be essential in driving cross-functional coordination and submission readiness.

Here’s What You’ll Bring to the Table:

• Bachelor’s degree in a scientific discipline or systems technology or equivalent

• 5-8 years of pharmaceutical experience working in a regulated, life science

• environment (pharmaceutical, biotechnology, consumer health)

• Advanced working knowledge of eCTD publishing systems, EDMS technology, and

• related publishing tools

• Extensive knowledge of European, EEA, Western Europe, US, and ROW electronic submission standards and industry trends for electronic submission requirements.

• Knowledge of SPOR, and IDMP requirements.

• A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)

• Excellent document formatting/troubleshooting skills in MS Word/PDF Professional

• Excellent English Language Skills.

At Moderna, we believe that when you feel your best, you can do your best work.

 That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.