Senior Submission Manager, Regulatory Operations

at  Moderna

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) with 2+ years in a management role.
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.).
Knowledge of CDISC (ADaM, SEND, SDTM).
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.
MS PowerPoint 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 .

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.
The Senior Manager, in collaboration with the Regulatory Lead, plans and prepares high-quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The Senior Manager provides technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation, and delivery of regulatory submissions, and acts as the primary point of contact for project and/or submission teams for major submissions. The Senior Manager will also support the Director of Regulatory Operations, or other members of the Regulatory Affairs, in activities related to setting standards, best practices, metrics collection, developing new procedures and work instructions, and lessons learned dissemination, and will assist in other activities as needed. It is expected that Senior Manager, will be deeply involved in publishing and submission management and will contribute to archiving and information management activities of the RA Department, along with the implementation of systems and tools.
Here’s What You’ll Do:Your key responsibilities will be:
Assist in strategic planning activities and translation of strategic decisions into operational plans related to all areas of regulatory operations.
In collaboration with the Regulatory Lead, manage the development and maintenance of a global submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing, and QC.
Ensure the project team has awareness and knowledge of e-submissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.
Provide operational oversight for the planning, preparation, publishing, validation, and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.
Lead the development and implementation of standards for dossier management, publishing, archiving, and submission processes for global regulatory authorities.
Manage activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health agencies.
Maintain technical expertise of regulatory requirements and ensure alignment with company processes and client requirements.
Act as a subject matter expert and system administrator for Moderna’s document management system.
Compile regulatory submissions for assigned submissions. Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed-upon timeframes. Manage submission and product life-cycle information.
Lead and manage special projects and teams as needed.

YOUR RESPONSIBILITIES WILL ALSO INCLUDE:

Deep involvement in publishing and submission management.
Contributing to archiving and information management activities of the RA Department.
Implementing systems and tools to streamline regulatory operations.

THE KEY MODERNA MINDSETS YOU’LL NEED TO SUCCEED IN THE ROLE:

Prioritize the platform: You will focus on optimizing and standardizing processes to ensure high-quality submissions and compliance with global standards, reflecting the overarching goal of prioritizing the platform over any single product.
Act with urgency: Given the fast-paced environment and the critical nature of regulatory submissions, you must act swiftly and efficiently to meet tight deadlines and ensure timely delivery of submissions.