Global Publishing Manager, Regulatory Affairs

at  Moderna

HERE’S WHAT YOU’LL BRING TO THE TABLE:

Bachelor’s degree or equivalent.
At least 5 years of experience as a regulatory Publisher in a pharmaceutical company or CRO, with 2+ years in a management role.
Experience leading the submission of MAA, INDs, NDAs, BLAs, Master Files, etc., formatted according to international eCTD requirements.
Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical or related industry.
Experience with electronic clinical document publishing standards/formats and global regulatory submission publishing standards/formats (e.g., eCTD, EU CTR).
Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools.
Familiarity with global Clinical and Regulatory HA requirements (e.g., FDA, ICH, EMA, MENA region, CH, MHRA).
Strong interpersonal and project management skills, with experience working in a complex, global cross-functional organization.
Highly motivated, organized, and detail-oriented team player.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Ability to readily adjust to change in a fast-paced environment and multitask.
Positive attitude and ability to effectively collaborate with peers, stakeholders, and cross-functional colleagues in a global team environment.
Strong technical skills.
Strong communication and business writing skills.
Fluency in English.
This role is based in Warsaw, Poland and is expected to be in office 70% of the time with flexibility to work from home up to 30%.
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.
As the Regulatory Operations Global Publishing Manager, you will be responsible for overseeing the planning, creation, and submission of regulatory submissions. Collaborating closely with the Regulatory Lead, you will manage and prepare high-quality global submissions, both in-house and via CROs, ensuring timely delivery of compliant submissions to global health authorities. You will serve as the primary point of contact for daily submissions and provide regulatory operations expertise to cross-functional submission project teams, promoting excellence in the planning, preparation, and delivery of regulatory submissions.
Here’s What You’ll Do:Your key responsibilities will be:
Compile, publish, and verify submission dossiers in accordance with international eCTD requirements.
Lead and manage the submission of MAA, INDs, NDAs, BLAs, Master Files, and other regulatory documents.
Work closely with team members to compile documents, review hypertext links, ensure PDFs are submission-ready, format tables and graphics, bookmark sections, and proof submissions according to internal standards.
Oversee the submission of eCTD sequences through health authority gateways.

YOUR RESPONSIBILITIES WILL ALSO INCLUDE:

Perform quality control (QC) of documents published by team members to ensure compliance with applicable guidance documents.
Assist with the remediation of Word documents to ensure proper format and compliance.
Mentor and train team members to enhance the quality of submissions across the team.
Participate in internal and external audits, maintaining compliance with department systems, such as project databases, timesheets, and training.
Contribute to the development of new publishing services and participate in department initiatives and process improvements.

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

We act with urgency: In this role, timely and accurate submissions are critical to ensuring that our groundbreaking treatments reach patients as quickly as possible. Your ability to work swiftly and efficiently will be essential to our success.
We prioritize the platform: Your work will be central to supporting Moderna’s broader mission by ensuring that all submissions are aligned with our global objectives and standards, thereby contributing to the broader success of our mRNA platform.