Director, Regulatory Science, Emerging Markets

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 footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.

An exciting opportunity has arisen for an experienced and dynamic Emerging Markets (EM) RA Strategy Lead to join our team. In this pivotal role, you will be responsible for developing and communicating the regulatory strategy for assigned projects within Emerging Markets. This will include designing and assessing regulatory strategy options on a regional/global basis in close collaboration with local RA teams.

Here's What You’ll Do:

Your key responsibilities will be:

• Leading core EM dossier preparation and compilation efforts.

• Liaising between global, local regulatory, and development teams to ensure the quality and timeliness of vaccine application documentation.

• Representing RA at relevant meetings and presenting agreed RA positions, negotiating with and influencing management across various functions to ensure regulatory compliance and program success.

Your responsibilities will also include:

• Working closely with the VP-RA EM and Global Regulatory Teams to develop and execute regulatory strategies in EM countries.

• Participating as a core member of the relevant Global Regulatory Sub-Team (GRST).

• Harmonizing new registration and regulatory processes across EM countries to improve efficiency and capacity.

• Providing strategic regulatory guidance for assigned projects and managing key stakeholder relationships.

The key Moderna Mindsets you’ll need to succeed in the role:

• Pursue options in parallel: You will be adept at managing multiple strategies and options simultaneously to ensure the most effective outcomes.

• Prioritize the platform: Your focus on the broader goals and the ability to prioritize tasks will be crucial in driving the success of our vaccine programs across diverse markets.

Here’s What You’ll Bring to the Table:

• Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)

• 12+ years of experience in the pharmaceutical industry. 7+ years of experience in Regulatory strategy

• Extensive experience in working with Emerging Markets region, including leadership experience at a senior level; this should include experience in regional or global level role

• Combined knowledge of scientific, regulatory and business issues to develop vaccines to meet required global, regional and local regulatory requirements

• Ability to network effectively, internally and externally to develop productive working relationships with key stakeholders, managing and influencing across a matrix

• Experience in an International environment/developing countries, exposure to and understanding of the regulatory environments in the EU and USA are required

• Sound understanding of regulatory systems, requirements processes to ensure knowledgeable discussion with internal and external stakeholders

• Cultural awareness as the role covers markets spanning Africa, Middle East, LATAM and Asia

• Strategic thinking, understanding of Moderna’s business and the external environmental factors that shape/drive the industry. Develop strategies to maximize outcomes for Moderna

• Effective execution of agreed strategies and able to adapt these to reflect changing conditions while still delivering required end results

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

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 premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• 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 people are 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 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 modernatx.com/careers 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 employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations 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 [email protected] .

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