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 expanding 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 Associate Director, Regulatory CMC, will be an integral part of Moderna’s team in Tokyo, focusing on developing and executing Japan Regulatory CMC strategies for both R&D and marketed products. This position plays a crucial role in aligning local regulatory strategies with global project goals, ensuring compliance with Japanese regulatory requirements. The role demands proactive engagement in Regulatory CMC discussions, effective risk management, and collaboration with health authorities. Additionally, the role involves guiding manufacturing and quality teams in regulatory compliance and post-market regulatory activities.
Here’s What You’ll Do:
Within 3 Months, You Will…
Develop a deep understanding of the landscape of mRNA therapeutics in the Oncology field, which is crucial for strategic planning in regulatory affairs.
Start actively contributing to regulatory submissions, including National Scientific Advice (NSA) meeting requests and clinical trial applications. This involves preparing necessary documentation and coordinating with teams to ensure submissions are comprehensive and compliant.
Begin engaging with project teams and committees to align on regulatory strategies, ensuring that regulatory plans are integrated with the broader objectives of the oncology programs.
Within 6 Months, You Will…
Take the lead in coordinating and managing regulatory submissions and amendments in EU and International markets. This includes overseeing the submission process and ensuring that all regulatory requirements are met.
Develop a comprehensive understanding of EU and International regulatory requirements, which is essential for successful regulatory strategy development and implementation.
Build and maintain effective communication with regulatory agencies relevant to assigned projects, ensuring that Moderna’s submissions and responses are timely and meet the expectations of regulatory bodies.
Within 12 Months, You Will…
Be fully integrated into the Regulatory Strategy team, driving major submissions and regulatory interactions. This means taking a leadership role in the preparation and submission of important regulatory documents.
Independently manage multiple projects, effectively balancing regulatory risks and strategic goals. This involves decision-making and strategy development for various regulatory initiatives.
Become a key contributor to Moderna’s success in transforming patient lives through mRNA science. This entails not only successful regulatory submissions but also contributing to the strategic direction of Moderna’s oncology portfolio.
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
7+ 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
MS 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.
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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