Submission Manager, Regulatory Operations at Moderna

Warsaw, Masovian Voivodeship, Poland -

Full Time

Start Date

Immediate

Expiry Date

21 Jan, 26

Salary

0.0

Posted On

23 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Submission Lifecycle Management, Regulatory Submissions, Cross-Functional Collaboration, eCTD Publishing, Document Management Systems, Operational Precision, Project Management, Regulatory Compliance, Digital Tools, Generative AI, Excellent English Language Skills, Document Formatting, Troubleshooting Skills, Knowledge Of SPOR, Knowledge Of IDMP Requirements

Industry

Biotechnology Research

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. You will be at the heart of Moderna’s 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. You’ll 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. Here’s What You’ll 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 Moderna’s internal systems and standards. Acting as the subject matter expert (SME) for Moderna’s 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 you’ll 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. You'll 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 we’re building go beyond any job description.” As a Submission Manager, you won’t just follow process — you'll 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. 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. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure 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 people are the driving force behind our scientific progress and our culture. Together, 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 modernatx.com/careers 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 person's 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. We’re 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 leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Manage and coordinate the planning, development, and delivery of complex regulatory submissions. Ensure timely, high-quality, and compliant submissions to global health authorities.