Sr. Specialist, Regulatory Operations

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 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 high-quality global submissions and ensuring timely delivery to health authorities worldwide. You will provide operational support to cross-functional submission teams, driving excellence in planning, preparation, and compliance, while serving as the key point of contact for project and submission activities.

Here’s What You’ll 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 e-submissions 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 high-quality submission packages.

• Collaborating on special projects and driving operational excellence in all submission-related 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 you’ll need to succeed in the role:

• We act with urgency: In regulatory submissions, timely and accurate delivery saves lives. You'll thrive in fast-paced environments where responsiveness is crucial.

• We behave like owners: Taking full accountability for your projects, you’ll own the success of submission strategies, embodying a solutions-oriented mindset.

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