Sr. Manager, Regulatory CMC, Global Regulatory Science

Moderna (Tokyo, 日本) フォロー 3日前

Full-time Japanese Swift Global Strategy Global Health Oral Communication

今すぐ適用する

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.

The Senior Manager, Regulatory CMC, based in our Tokyo office, will be instrumental in developing and executing Japan Regulatory CMC strategies for both R&D projects and post-marketed products. This role demands strategic oversight of the Japan NDA processes and a deep involvement in managing Regulatory CMC/compliance and related activities for marketed products.

Here’s What You’ll Do:

Your key responsibilities will be:

Developing and implementing Japan CMC regulatory strategies for submissions from CTN through JNDA, ensuring alignment with global CMC project strategies.
Identifying regulatory CMC risks, leading discussions and interactions with health authorities to manage critical regulatory issues.
Preparing high-quality CMC submission dossiers that align with global strategies while adhering to Japanese regulatory standards.

Your responsibilities will also include:

Providing Japan CMC regulatory guidance to manufacturing and quality teams, evaluating CMC change controls for regulatory impact on products in Japan.
Leading CMC aspects of post-marketed regulatory activities, including dossier preparation and managing health authority inquiries to secure timely regulatory approvals.
Coaching and providing technical advice to colleagues within the team.

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

We act with urgency: Your swift and proactive regulatory strategies will contribute directly to Moderna's quick response to health needs.
We prioritize the platform: Your focus on aligning Japan’s CMC regulatory strategies with our global objectives underscores our commitment to a unified approach in advancing mRNA technology.

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

Minimum Qualifications

BA/BS degree in a scientific/engineering discipline
10+ years of experience in the pharmaceutical/biotech industry
5+ years of experience in Regulatory CMC, both R&D and post-marketed field
Strong knowledge of current Japanese regulations and regulatory trend, especially in CMC field
Strong knowledge of cGMP
Strong experience with CTD format and content regulatory filings
Strong written and oral communication in English along with Fluency in Japanese

Preferred Qualifications

BA/BSc degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
5+ years of experience in Biologics and vaccine focused Regulatory CMC

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.

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].