Submission Manager, Regulatory Operations

The Role:

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

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

Modernas 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 Modernas global business operations. Were inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.

You will be at the heart of Modernas global regulatory operations managing and coordinating the planning development and delivery of complex regulatory submissions that support the advancement of our mRNA pipeline. This role requires deep expertise in submission lifecycle management with a strong focus on operational precision and cross-functional collaboration. As the primary submission lead for key projects you will ensure timely high-quality and compliant submissions to global health authorities. Youll partner closely with Regulatory Leads CROs and publishing vendors acting as the go-to expert for all operational aspects of submission delivery. This is a Warsaw-based individual contributor role offering the opportunity to support global regulatory strategy and expand your exposure to digital tools and generative AI applications in regulatory operations.

Heres What Youll Do:

Your key responsibilities will be:

• Leading the creation and maintenance of comprehensive submission content plans tracking each component from drafting to final publishing and QC.

• Acting as the primary point of contact for cross-functional teams on submission operations including strategic input on submission planning and execution.

• Delivering high-quality global submissions (e.g. BLA MAA Variations) to regulatory authorities in compliance with applicable guidelines and timelines.

• Managing submission lifecycle data and coordinating distribution of submissions to health authorities CROs and internal stakeholders.

• Ensuring submission planning aligns with global requirements and regional nuances (eCTD NeeS etc.) providing expert guidance to teams accordingly.

• Providing full operational oversight of submission activities from publishing through to final validation and delivery.

Your responsibilities will also include:

• Managing and overseeing external publishing vendors to ensure timely and accurate preparation of submission packages.

• Maintaining up-to-date knowledge of global regulatory requirements and ensuring alignment with Modernas internal systems and standards.

• Acting as the subject matter expert (SME) for Modernas document management system in the regulatory operations context.

• Communicating project and submission status risks and accomplishments to stakeholders and management with clarity and precision.

• Leading and contributing to special projects to improve operational excellence and regulatory delivery.

• Bringing forward opportunities to apply digitization and generative AI tools in the regulatory submission process to enhance speed quality and scalability.

The key Moderna Mindsets youll need to succeed in the role:

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  This role is deeply integrated into our digital operations environment. Youll thrive by leveraging our document and submission management systems and contributing to ongoing automation and AI integration initiatives that enhance regulatory processes.

• We behave like owners. The solutions were building go beyond any job description.
  As a Submission Manager you wont just follow process youll own the delivery of submissions and look for ways to improve the end-to-end pathway. Your leadership in submission execution directly contributes to the acceleration of our life-changing therapies.

Heres What Youll Bring to the Table:

• Bachelors 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. Thats why our global benefits and well-being resources are designed to support youat 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
• Savingsandinvestments
• 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.

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our peopleare the driving force behind our scientific progress and our we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .

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