The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through m RNA 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 m RNA 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 Seoul, a city at the forefront of South Korea's thriving biotech industry. Our Seoul office will focus on commercial operations ensuring the delivery of our groundbreaking products to the Korean market. We're seeking talents who are passionate about making a significant impact on global health through our innovative m RNA technology.

This is a fixed-term contract to support backfill of maternity leave (12+ months).

The Manager, Regulatory Affairs-Korea, based in Seoul, will have the opportunity to lead the regulatory strategy in Korea and provide regulatory support to the Director of Regulatory Science Korea and Global Regulatory Teams. Moderna looks for an agile Regulatory Affairs Manager able to anticipate and address the challenges involved in supporting interactions with the Ministry of Food and Drug Safety (MFDS) for messenger RNA therapeutics as an unprecedented new drug modality. The manager will provide regulatory support across the Therapeutic Areas based on m RNA technology in Korea. This support includes, but is not limited to, managing regulatory interactions with MFDS regarding marketing authorization applications in Korea as well as post-approval CMC variations. This person will work closely with various functions in the company to provide regulatory guidance to support overall business activities from IND to life cycle management.

Your key responsibilities will be:
Responsible for regulatory aspects of assigned projects or programs.

Support Director, Regulatory Science Korea and South East Asia and Global Regulatory Teams and International Regulatory Affairs regarding the development and execution of regulatory strategy in Korea.

Develop and contribute to content, format, and accountability for regulatory submissions and related supplements and amendments, including Korea regulatory documents such as MFDS submission documents, meeting requests, orphan drug designations, RTQs, post-approval variations, etc.

Identify and assess regulatory risks for assigned projects or programs.

Keep close contact with relevant departments in MFDS relevant to assigned projects or programs, as appropriate.

Ability to work both independently and within project teams, committees, etc., to achieve business goals and objectives.

Prepare and deliver effective communications and presentations for external and internal audiences.

Create and maintain Korea parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information.

Your responsibilities will also include:
Prepare and deliver effective communications and presentations for external and internal audiences.

Create and maintain Korea parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information.

The key Moderna Mindsets you’ll need to succeed in the role:
Act with urgency : This role requires a proactive approach to regulatory challenges and the ability to respond quickly to new data and regulatory requirements.

Prioritize the platform : Emphasis on understanding and advocating for the broader m RNA technology platform over individual products.

Here’s What You’ll Bring to the Table:
BA/BS degree in a scientific major (eg. Biology, Biochemical, Bioengineering, Pharmacy) required. Advanced degree is preferred. Registered Pharmacist is preferred.

5+ years of experience in the Regulatory Affairs function in multinational Pharmaceutical companies

Strong knowledge of current Korea 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 regulatory filings

Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in Korea and International countries

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 program’s critical regulatory milestones

Effectively communicate the regulatory strategy, risks, mitigations and overall plans to functional management and global project teams , as relevant

Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Business level English is required.

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 m RNA 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 leavesandaccommodations@modernatx.com .
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