Sr. Specialist

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 Senior Submissions Specialist, Regulatory Operations, you will play a vital role in coordinating and tracking regulatory submissions, ensuring that high-quality global submissions are prepared and delivered in compliance with regulatory requirements. Working closely with the Regulatory Lead, you will manage submissions both in-house and via CROs, guaranteeing timely and accurate submissions to global health authorities. Your responsibilities will also include providing operational support to cross-functional teams, facilitating excellence in planning, preparation, and submission delivery. As a point of contact for submission teams, you will ensure that all regulatory requirements are met and that submission processes run smoothly.

Here’s What You’ll Do:

Your key responsibilities will be:

• Submission Coordination: Coordinate the development and maintenance of submission content plans, including tracking documents from authoring to approval, publishing, and quality control, with guidance from senior Regulatory Operations personnel.
• Global Submissions Management: Ensure that project teams are knowledgeable about e-submissions (eCTD, NeeS, etc.) and life cycle management concepts, communicating regional differences as necessary within the global submission preparation context.
• Communication and Reporting: Effectively communicate project status, issues, schedules, and accomplishments to management and stakeholders as needed.
• Operational Support: Provide operational support for the planning, preparation, publishing, validation, and timely submission of various regulatory applications (BLA, MAA, Variations, etc.) to global health agencies.

Your responsibilities will also include:

• Vendor Coordination: Coordinate activities of publishing vendors in preparing high-quality submission packages and ensuring their timely delivery to health agencies.
• Technical Expertise: Maintain up-to-date knowledge of regulatory requirements, ensuring alignment with company processes and client needs.
• Distribution Management: Coordinate the distribution of submissions to all relevant parties (HA, CRO) within agreed timeframes and manage submission and product life-cycle information.
• Project Leadership: Lead and coordinate special projects as needed to enhance submission processes and outcomes.

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

• Prioritize the Platform: This role demands a strong focus on how submission processes and strategies align with and support Moderna's broader platform goals. By prioritizing efficient and effective submissions, you will directly contribute to the success and scalability of Moderna’s mRNA technology.
• Act with Urgency: Timely and compliant submissions are critical in this role. You will need to act with urgency, ensuring that submissions are prepared and delivered within strict deadlines, thereby accelerating Moderna’s ability to bring innovative treatments to patients.

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

• 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
• Excellent English Language Skills.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• 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, and a discretionary year-end shutdown
• Educational resources
• 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 employment opportunity 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 also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations 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.

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