Associate Director, Regulatory Science, CTA

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 lead and continue to expand Modernas Clinical Trial Application (CTA) regulatory group ensuring the flawless execution of global CTA submissions and maintenance activities. This role is pivotal in coordinating regulatory dossier preparation overseeing international health authority submissions and optimizing systems and processes in partnership with internal and external stakeholders. Acting as a strategic anchor within the Global Regulatory Science (GRS) team youll liaise across Clinical Development Regulatory Country Leads and CROs to ensure the effective delivery of regulatory milestones that support our mRNA clinical pipeline. Positioned in Warsaw this leadership role offers a high-impact platform for influencing both global regulatory outcomes and digital enablement initiatives in clinical development.

Heres What Youll Do:

Your key responsibilities will be:

• Leading and expanding the CTA regulatory team within Modernas Global Regulatory Science organization providing strategic and operational direction.

• Ensuring excellence in planning execution and quality of global Clinical Trial Application submissions across the portfolio.

• Coordinating globally with Clinical Operations Therapeutic Area leads Country Regulatory Leads and external CROs.

• Managing end-to-end CTA submission activities directly or through local resources to ensure timely and compliant execution.

• Overseeing global implementation of CTA strategy and lifecycle maintenance of submissions.

• Ensuring alignment with all applicable country-specific requirements and regulatory guidance.

Your responsibilities will also include:

• Partnering with the Digital team to implement robust digital tools for tracking country requirements product CTAs and key performance metrics.

• Supporting the preparation of dossiers and operational components of submissions including M1 administrative forms translations and packaging artwork coordination as needed.

• Providing oversight and direction to CROs regarding CTA execution and query resolution.

• Acting as a subject matter expert in European clinical trial regulations and supporting other emerging global regulatory initiatives.

• Educating cross-functional teams on evolving regulatory requirements and their impact on clinical strategies.

• Maintaining comprehensive regulatory tracking systems and submission archives to ensure audit readiness and process integrity.

• Participating in process improvement projects and contributing to the evolving regulatory framework within GRS and International HQ.

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.
  Your leadership in digitalizing CTA tracking and performance metrics will not only improve transparency and complianceit will drive scalable tech-enabled regulatory operations that improve time-to-clinic.

• We behave like owners. The solutions were building go beyond any job description.
  This role requires taking end-to-end ownership of the global CTA submission processboth in managing a growing team and influencing critical collaborations across internal and external partners to accelerate clinical readiness.

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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