Submissions Manager, Regulatory Operations

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.

In the position of Regulatory Operations Submission Manager, you will be at the forefront of ensuring the smooth planning, management, and tracking of regulatory submissions. Your collaboration with the Regulatory Lead will be crucial in planning and preparing high-quality global submissions, either in-house or via CRO, ensuring timely delivery to global health authorities. This role demands a high level of expertise in regulatory operations to support cross-functional submission project teams, ensuring excellence in planning, preparation, and delivery of regulatory submissions. You will be the primary contact for major submissions, providing vital support and guidance.

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

Your key responsibilities will be:

• Manage the development and maintenance of a submission content plan, tracking documents from authoring to approval, publishing, and QC.

• Act as the global submissions expert, ensuring project teams are well-informed about e submissions (eCTD, NeeS, etc.) and lifecycle management concepts, communicating regional differences as needed.

• Communicate project status, issues, schedules, and accomplishments to management and stakeholders.

• Provide operational oversight for the planning, preparation, publishing, validation, and submission of applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.

• Manage publishing vendors to prepare high-quality submission packages and ensure their timely delivery to health agencies.

Your responsibilities will also include:

• Maintain technical expertise in regulatory requirements, aligning with company processes and client requirements.

• Act as a subject matter expert for Moderna’s document management system.

• Compile regulatory submissions and coordinate their distribution to all concerned parties (HA, CRO) within agreed timeframes.

• Manage submission and product life-cycle information.

• Lead and manage special projects as needed.

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

• We act with urgency: Your timely management of submissions will be critical to meeting global health authorities' deadlines.

• We prioritize the platform: Utilizing digital tools and systems will enhance submission efficiency and accuracy.

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

• A Bachelor’s degree in a scientific discipline or systems technology, or equivalent experience.

• 5-8 years of experience in the pharmaceutical industry, specifically within 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 North American/Global submission standards (FDA, Health Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.).

• Proficiency in CDISC (ADaM, SEND, SDTM).

• A demonstrated ability to lead and collaborate effectively with cross-functional teams (Regulatory, clinical, nonclinical, etc.).

• Excellent document formatting and troubleshooting skills in MS Word and PDF Professional.

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 mind