Manager, Global Regulatory Science

vor 2 Wochen

Basel, Schweiz Moderna Vollzeit

**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 enhancing its global presence in two key European locations: Basel, the vibrant hub of pharmaceutical innovation in Switzerland, and Warsaw, Poland, renowned for its rich scientific and technological heritage. In Basel, we are furthering our mission of delivering the greatest possible impact to people through mRNA medicines as we expand our international operations and commercial activities. Meanwhile, our Warsaw hub serves as an international business services center, providing critical functions to meet the growing demand of Moderna's global operations. We invite global talents to join us in these exciting journeys of transforming medicine and impacting lives worldwide, whether from the heart of European pharmaceutical innovation in Basel or at the crossroads of scientific excellence in Warsaw.

As the Manager Global Regulatory Science and CTA Coordinator, you will provide effective operational and regulatory support for assigned regulatory submission and maintenance activities. This includes the preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives, and overseeing the regulatory submission of CTAs to national Health Authorities worldwide.

**Your key responsibilities will be**:
Guiding and coordinating the CTA dossier compilation for submission.

Supporting regulatory Clinical Trial Applications submission activities directly to Health Authorities.

Liaising with and providing oversight to CROs supporting CTA submissions and query management.

Driving the implementation of the global CTA submission strategy.

Ensuring mandatory regulatory requirements comply with country-specific requirements.

**Your responsibilities will also include**:
Interacting with cross-functional teams to ensure optimal execution of regulatory strategies.

Maintaining good knowledge of regulatory requirements and guidelines, especially European regulations on Clinical Trials.

Communicating and guiding teams on European regulatory requirements and changes.

Leading process improvement initiatives within GRS or the International HQ.

Maintaining effective archiving and submissions/approvals tracking records.

**The key Moderna Mindsets you’ll need to succeed in the role**:
**Pursue options in parallel**: Your role will require managing multiple tasks and projects simultaneously, making quick and effective decisions.

**Act with urgency**: The fast-paced nature of regulatory submissions demands prompt action and responsiveness to ensure success.

**Here’s What You’ll Bring to the Table**:
Degree in Life Science or related discipline

5+ years of experience in the Pharmaceutical industry.

4+ years of experience in Regulatory

Good knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)

Regulatory submission experience and expertise in regulatory requirements, systems and working practices

Good project management experience and leadership skills

Excellent knowledge of English, spoken and written

Proven ability to work within multi-functional teams, building strong and productive relationships across an organization.

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 chan

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