Director, Regulatory CMC

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 in Tokyo, a city known for its blend of tradition and innovation. Our new commercial office here will focus on bringing our advanced mRNA products to the Japanese market. Nestled in the heart of Tokyo's vibrant landscape, we're looking to integrate into the local biotech scene while contributing our global expertise. We welcome professionals who are passionate about making a difference in healthcare to join our team. Here you'll be part of a community dedicated to simple yet profound goals: enhancing health outcomes and providing cutting-edge treatments in Japan. Join us in Tokyo where your efforts will help shape the future of medicine in an environment that values both tradition and innovation.

An exciting opportunity has arisen for a dedicated Director, Regulatory CMC to join our Tokyo-based team. This pivotal role involves leading the regulatory CMC Japan team and overseeing all aspects of CMC and Quality related regulatory applications, submissions, and compliance support for the development of our global products. Your expertise will contribute significantly to preparing our groundbreaking mRNA medicines for successful market entry and ensuring compliance with health authority guidelines.

Here’s What You’ll Do:

Your key responsibilities will be:

• Developing and implementing effective CMC regulatory strategies for submissions such as CTN, BLA, and MAA while identifying regulatory risks.

• Providing expert guidance on regulatory CMC aspects of product development projects and ensuring submission readiness of documents.

• Leading discussions and interactions with health authorities to facilitate the review and approval process of submissions.

• Establishing regulatory processes and procedures to support CMC components of regulatory submissions, and managing the regulatory CMC Japan team.

Your responsibilities will also include:

• Supporting the creation and maintenance of CMC submission templates and providing CMC regulatory guidance to manufacturing and quality teams.

• Evaluating CMC change controls and interpreting regulatory guidance documents, regulations, and directives.

• Advising Manufacturing, Quality, and Process/Analytical Development groups on their applicability and impact on internal programs.

• Leading oversight of multiple programs in various therapeutic areas, including vaccines, oncology, and rare diseases, and developing team members to nurture their talent.

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

Your role will require a strategic approach to pursue options in parallel for the most effective regulatory outcomes, and an innovative mindset to question convention, ensuring Moderna remains at the forefront of the mRNA technology revolution.

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

Minimum Qualifications

• BA/BS degree in a scientific/engineering discipline

• 12+ years of experience in the pharmaceutical/biotech industry

• 7+ years of experience in Regulatory CMC

• Strong knowledge of current Japan regulatory landscape and ICH guidelines

• Strong knowledge of cGMP

• Strong experience with CTD format and content regulatory filings

• Demonstrated strong leadership skill both project lead. Line management experience is desirable

• Exceptional written and oral communication in English and Japanese

Preferred Qualifications

• MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable

• 15+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus

• 10+ years of experience in Biologics focused Regulatory CMC

• Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases)

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, the infrastructure 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.
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 proud to be an equal opportunity workplace and is an affirmative action employer.

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. Moderna is an E-Verify Employer in the United States. 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 to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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