Senior Submissions Specialist, Regulatory Operations

If you're interested in this role, please apply in English and include an English version of your Resume/CV. The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its international business services hub in Warsaw, supporting our growing global operations. We welcome professionals ready to help advance our mission and shape the future of mRNA medicines. As a Senior Submissions Specialist within Regulatory Operations, you will play a critical role in coordinating, preparing, tracking, and delivering high-quality regulatory submissions to health authorities around the world. Working in close collaboration with Regulatory Leads, cross-functional submission project teams, CROs, and publishing vendors, you will bring operational excellence to the end-to-end submission process, from content planning and document authoring through publishing, quality control, validation, and final delivery. As an individual contributor with a global remit, you will act as a key point of contact for project and submission teams, applying deep knowledge of e-submission standards, regulatory requirements, and lifecycle management to ensure submissions are compliant, accurate, and delivered on time. This role offers the opportunity to combine regulatory expertise, digital ways of working, and emerging Generative AI tools to strengthen submission planning, simplify complex workflows, improve knowledge sharing, and help Moderna continue advancing the way regulatory operations are delivered globally. Here's What You'll Do: Coordinate the development and maintenance of detailed submission content plans, with guidance from senior Regulatory Operations personnel, capturing all source submission content including documents, data, and other required materials, and tracking those components from authoring through approval, publishing, quality control, and final submission. Serve as a global submissions professional who ensures project teams have the appropriate awareness and knowledge of electronic submission standards and formats, including eCTD and NeeS, as well as regulatory lifecycle management concepts. Communicate regional regulatory differences, requirements, and submission considerations within the context of global submission preparation, helping cross-functional teams navigate the technical and operational complexity of submissions across markets. Provide operational support for the planning, preparation, publishing, validation, and timely delivery of assigned regulatory applications and lifecycle submissions, including BLAs, MAAs, updates, amendments, variations, and other regulatory dossiers submitted to global health authorities. Work closely with Regulatory Leads and cross-functional submission project teams to promote excellence in submission planning, preparation, coordination, and delivery. Act as a point of contact for project and/or submission teams, providing clear regulatory operations guidance and helping coordinate activities and dependencies across the submission lifecycle. Effectively communicate project status, submission schedules, accomplishments, risks, issues, and dependencies to relevant management and stakeholder groups as required. Coordinate the activities of external publishing vendors to support the preparation of high-quality, technically compliant submission packages and ensure their timely delivery to health authorities. Maintain strong technical expertise in evolving global regulatory requirements and electronic submission standards, ensuring submission activities remain aligned with Moderna processes and applicable client requirements. Coordinate the distribution of regulatory submissions to all relevant parties, including health authorities and CRO partners, within agreed timelines. Coordinate submission and product lifecycle information to support accurate and consistent management of regulatory activities throughout the product lifecycle. Lead and coordinate special Regulatory Operations projects as required, bringing structured planning, strong execution, and cross-functional collaboration to complex operational challenges. Explore opportunities to apply digital capabilities and Generative AI tools within Regulatory Operations, helping accelerate appropriate administrative and knowledge-based activities while maintaining the quality, control, compliance, and human oversight required for regulatory submissions. The key Moderna Mindsets you'll need to succeed in the role: "We act with dynamic range, driving strategy and execution at the same time at every step." "We digitize everywhere possible using the power of code to maximize our impact on patients." Here's What You'll Need (Basic Qualifications) Bachelor's degree in a scientific discipline or systems technology or equivalent 3-5 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health) Working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools (Veeva RIM). Working 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 collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.) Strong attention to detail and ability to work in a fast-paced environment Excellent document formatting/troubleshooting skills in MS Word/PDF Professional Proficiency in English (verbal and/or written) required due to global collaboration needs. Our Working Model 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. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Pay \& Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you---at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being with access to fitness, mindfulness, and mental health support Family building benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future 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. 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 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 [email protected]. - 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 [email protected] 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