Senior Manager, Regulatory Science, EEMEA

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 in London a global hub for scientific research and innovation. Our London office focuses on commercial operations ensuring the delivery of our revolutionary products to the UK market. Were seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.

In this sole contributor position based in London the Sr. Manager Regulatory Science EEMEA will drive regional regulatory strategy and execution across Eastern Europe the Middle East and Africa. This pivotal role will support both the Director of Regulatory Affairs EEMEA and the wider Global Regulatory and Cross-Functional Teams. You will play a central role in navigating the complex regulatory landscape for a novel therapeutic modalitymessenger RNAacross multiple therapeutic areas. Your responsibilities will span from early development through life cycle management including new marketing authorization applications post-approval commitments and line extensions. You will also serve as a key regulatory interface with EEMEA Health Authorities and regional partners shaping regulatory pathways that bring innovative mRNA medicines to patients across diverse markets.

Heres What Youll Do:

Your key responsibilities will be:

• Leading the regulatory aspects of assigned projects and programs across the EEMEA region.

• Supporting the Director Regulatory Affairs EEMEA in collaboration with Global Regulatory Teams and Regional/Country Cross-Functional Teams.

• Managing the development content and format of regulatory submissions including submission dossiers orphan drug designations meeting requests priority review applications and safety reports.

• Providing regulatory expertise from early clinical stages (IND) through commercialization and beyond.

• Acting as the primary regulatory point of contact for interactions with relevant Health Authorities and external consultants/partners for your assigned projects.

Your responsibilities will also include:

• Managing post-approval lifecycle activities including variations and commitments for approved products.

• Identifying and assessing regulatory risks across your portfolio.

• Preparing and delivering strategic communications and presentations to both internal stakeholders and external regulatory bodies.

• Ensuring alignment of regional regulatory strategy with global development plans.

• Advising regional and global teams on evolving regulatory requirements across the EEMEA region.

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

• We obsess over learning. We dont have to be the smartestwe have to learn the fastest.
  You will be entering a rapidly evolving therapeutic and regulatory space where success hinges on your ability to quickly absorb interpret and act on changing regulatory guidelines and local expectations across a diverse region.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  As part of a digitally native biotech company your work will intersect with Modernas technology-driven approach to data documentation and submission generationallowing you to push regulatory science into the future while unlocking the potential of Generative AI tools in the process.

Heres What Youll Bring to the Table:

• BA/BS degree in a scientific major (eg. Biology Biochemical Bioengineering Pharmacy) required.

• 10 years of experience in the Pharmaceutical industry

• 7 years of experience in Regulatory Affairs

• Strong knowledge of current EEMEA and International regulations including the US and the EU related to the clinical nonclinical and CMC development of biologic products

• Strong experience with CTD format and content of regulatory filings

• Knowledge of and broad experience with regulatory procedures and legislation for drug development product registration line extension and license maintenance in EEMEA

• Able to help create and maintain parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information

• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements

• Ability to work independently to manage multiple projects in a fast-paced environment

• Ability to effectively collaborate effectively in a dynamic cross-functional matrix environment to drive meeting each programs critical regulatory milestones

• Able to effectively communicate the regulatory strategy risks mitigation and overall plans to Project Teams and senior management as relevant

• Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Business level fluency in English is required. Fluency in Arabic is an advantage.

• 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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