Sr Specialist Regulatory Operations

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.

The Senior Submissions Specialist Regulatory Operations is a vital part of our global Regulatory Operations team. In this role you will coordinate and track regulatory submissions partnering with the Regulatory Lead to prepare highquality global submissions and ensuring timely delivery to health authorities worldwide. You will provide operational support to crossfunctional submission teams driving excellence in planning preparation and compliance while serving as the key point of contact for project and submission activities.

Heres What Youll Do:

Your key responsibilities will be:

• Coordinating the development and maintenance of a submission content plan with guidance from senior Regulatory Operations personnel.

• Ensuring project teams understand and align with global esubmissions standards (eCTD NeeS) and life cycle management concepts while navigating regional differences effectively.

• Providing operational support for the planning preparation publishing validation and submission of applications such as BLAs MAAs and Variations and ensuring their timely delivery to global health authorities.

• Leading and coordinating activities with publishing vendors to produce highquality submission packages.

• Collaborating on special projects and driving operational excellence in all submissionrelated processes.

Your responsibilities will also include:

• Maintaining technical expertise of regulatory requirements to ensure compliance with company and client standards.

• Managing distribution of submissions to health authorities CROs and other stakeholders within agreed timeframes.

• Effectively communicating project status schedules and deliverables to management and stakeholders.

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

• We act with urgency: In regulatory submissions timely and accurate delivery saves lives. Youll thrive in fastpaced environments where responsiveness is crucial.

• We behave like owners: Taking full accountability for your projects youll own the success of submission strategies embodying a solutionsoriented mindset.

Heres What Youll Bring to the Table:

• Bachelors degree in a scientific discipline or systems technology or equivalent

• 35 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 crossfunctionally (Regulatory clinical nonclinical etc.

• Strong attention to detail and ability to work in a fastpaced environment

• Excellent document formatting/troubleshooting skills in MS Word/PDF Professional

• Excellent English Language Skills.

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 .