Global Senior Specialist Publisher Regulatory Affairs

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives. Modernas 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 Modernas global business operations. Were inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.

In the position of Regulatory Operations Senior Publishing Specialist you will be responsible for the planning creation and submission of regulatory submissions. Collaborating with the Regulatory Lead you will prepare highquality global submissions whether inhouse or via CRO ensuring their timely delivery to global health authorities. You will provide regulatory operations expertise to crossfunctional submission project teams enhancing the planning preparation and delivery of regulatory submissions. Acting as the primary contact for daily submissions for major projects you will embody Modernas commitment to urgency and ownership in delivering transformative medicines to patients.

Heres What Youll Bring to the Table:

Your key responsibilities will be:

• Compile publish and verify submission dossiers in accordance with international eCTD requirements and regulatory guidelines.

• Lead 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 submissionready format tables and graphics bookmark sections and proof submissions according to internal standards.

• Develop new processes and procedures to enhance efficiency and accuracy during the submission process.

• Collaborate with submissions management to build technically valid and highquality dossiers.

Your responsibilities will also include:

• Manage the submission of eCTD sequences through health authority gateways.

• Perform quality control (QC) of documents published by other 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 other team members to increase the quality across the team.

• Participate in internal and external audits maintaining compliance with department systems e.g. project database timesheets training.

• Contribute to the development of new publishing services and actively participate in department initiatives and process improvements.

• Maintain a strong understanding of applicable regulatory guidelines and ensure the achievement of individual utilization targets.

The key Moderna Mindsets youll need to succeed in the role:

• We act with urgency: Your role in ensuring timely and accurate submissions is critical to meeting regulatory deadlines.

• We prioritize the platform: Leveraging digital tools and systems will enhance submission efficiency and accuracy.

Heres What Youll Bring to the Table:

• A Bachelors degree or equivalent.

• At least 5 years of experience as a regulatory Publisher in a pharmaceutical company or CRO.

• 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 crossfunctional organization.

• Highly motivated organized and detailoriented team player.

• Analytical thinker with excellent problemsolving skills and the ability to adapt to changing priorities and deadlines.

• Ability to readily adjust to change in a fastpaced environment and multitask.

• Positive attitude and ability to effectively collaborate with peers stakeholders and crossfunctional colleagues in a global team environment.

• Strong technical skills.

• Strong communication and business writing skills.

• Fluency in English.

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and wellbeing resources are designed to support youat work at home and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to wellbeing
• 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 yearend shutdown
• Savingsandinvestments
• Locationspecific 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 theinfrastructure to reimagine how medicines are created and delivered and a worldclass 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 peopleare 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 nondiscrimination for all employees and qualified applicants without regard to a persons 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.

Were 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 .