Moderna Therapeutics

The Role:

The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in supporting the Health Agency interactions in EU and International markets for messenger RNA therapeutics as unprecedented new drug modality.

The Manager will provide regulatory clinical support across Therapeutic Areas including Infectious Diseases. Their support includes but is not limited to requesting Scientific Advice meetings at the national and Pan-EU level, managing the marketing authorization applications in EU and International markets, and other regulatory submissions (orphan drug designations, pediatric plans, PRIME, DSURs, MAA, etc.)

Here's What You’ll Do:

• Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including National Scientific Advice (NSA) meeting requests, briefing books, clinical trial applications, orphan drug designations, pediatric plans, PRIME, Sakigake applications, DSURs, new MAA and lifecycle management etc.)
• Work with the Sr Director Regulatory Strategy, the Project team, the RA International team, the International Reg-CMC, and Global Regulatory Sub-Teams regarding the development and execution of regulatory strategy in the EU and International countries in collaboration with the Country Leads
• Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs
• Identify and assess regulatory risks for assigned projects or programs
• Contact relevant regulatory agencies relevant to assigned projects or programs, as appropriate
• Ability to work both independently and within project teams, committees, etc. to achieve group goals
• Accountable for tracking, following up and archiving correspondence, regulatory commitments, and queries from International Health Agencies

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

• Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
• 5+ years of experience in the pharmaceutical industry. 3+ years of experience in Regulatory strategy
• Strong knowledge of current EU and International regulations related to the clinical, nonclinical, and CMC development
• 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 the EU 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
• Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned
• 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, 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)