Senior Specialist, Global Regulatory Science, CTA Coordinator

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.

You will play a pivotal role in driving the operational and regulatory strategy for clinical trial submissions across a dedicated therapeutic area. As the regulatory point of contact you will oversee dossier development and CTA execution while liaising with internal teams CROs and regulatory authorities to ensure compliant and timely global submissions. This is an exciting opportunity to operate at the intersection of science regulation and innovationwhere you will shape the trajectory of our clinical programs and ensure Moderna remains at the forefront of regulatory excellence.

Working from Warsaw youll be at the heart of global CTA operations bringing together Modernas deep clinical pipeline and evolving regulatory landscape particularly within the European environment. Youll independently manage submission strategies partner cross-functionally to resolve regulatory risks and ensure alignment with global requirementsall while contributing to the acceleration of our mRNA platform and advancing life-changing therapies. You will also have the opportunity to engage with Generative AI tools to optimize regulatory planning and execution.

Heres What Youll Do:

Your key responsibilities will be:

• Oversee assignment milestones and deliverables of the clinical trial program within a designated therapeutic area.

• Manage regulatory Clinical Trial Application (CTA) submission activities for assigned trials coordinating directly with global health authorities or enabling submission by in-country teams.

• Lead the implementation of the global CTA submission strategy across the trial lifecycle ensuring robust compliant and high-quality submissions.

• Support the planning and execution of CTA submissions in collaboration with Clinical Operations Therapeutic Areas GRLs regional strategists Country Regulatory Leads and CROs.

• Prepare and/or coordinate the preparation of regulatory documentation to support CTA and amendment submissions worldwide.

• Ensure compliance with evolving country-specific regulatory requirements for CTAs and related submissions.

Your responsibilities will also include:

• Maintain oversight of CRO performance related to CTA submissions and query management.

• Coordinate operational activities including administrative form completion translation management and artwork preparation as required for Module 1 dossiers.

• Facilitate cross-functional collaboration (Regulatory Clinical Development Clinical Operations Safety CMC) to execute regulatory strategy effectively.

• Monitor and anticipate regulatory risks developing proactive mitigation strategies.

• Educate cross-functional teams on European regulatory frameworks and emerging guidelines.

• Maintain accurate submission and approval tracking records ensuring proper archiving of regulatory documentation.

• Contribute to regulatory process improvement initiatives within Global Regulatory Science (GRS) or Modernas International HQ as needed.

• Stay current on regulatory trends especially in the EU clinical trial landscape and novel product guidelines.

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

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  In this role your ability to integrate digital toolsincluding exposure to Generative AIinto regulatory workflows will be essential. By streamlining dossier preparation and submission tracking you will help accelerate the path from clinical trial to patient access.

• We behave like owners. The solutions were building go beyond any job description.
  Operating as a regulatory sole contributor your success will depend on your ownership mindset. Youll proactively drive regulatory excellence bring forward innovative solutions and champion compliance through every phase of clinical development.

Heres What Youll Bring to the Table:

• Degree in Life Science or related discipline

• 8 years of experience in the pharmaceutical industry

• 7 years of experience in Regulatory affairs incl. conducting of clinical studies

• Proven leadership in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union

• Solid knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)

• Detailed regulatory submission experience and regulatory knowledge of CTR and CTIS

• Proven project management experience and leadership skills some people management experience preferred

• Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.

• Verified ability to lead multi-functional teams building strong and productive relationships across an organization.

• A desire to be part of a high-growth transformational company that is Bold Relentless Curious and Collaborative

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being 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 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 global recharge days and a discretionary year-end shutdown
• Savingsandinvestments
• 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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 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 opportunity in employment and non-discrimination 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 .

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