Associate Director, Global Regulatory Science

vor 5 Monaten

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 solidifying its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.

The Associate Director, Global Regulatory Science - CMC will take charge of leading regulatory CMC strategy and execution for one or more transformative medicine programs. This pivotal role involves developing and implementing global regulatory CMC strategies and collaborating with key stakeholders to align these strategies with regulatory requirements and business priorities.

**Here's What You’ll Do**:Your key responsibilities will be**:
Developing and executing effective regulatory CMC strategies for global IND/CTA/BLA/MAA submissions.

Leading regulatory CMC discussions and interactions with Health Authorities to facilitate the review and approval process.

Providing regulatory CMC advice to manufacturing and quality teams and reviewing documents for submission readiness.

**Your responsibilities will also include**:
Identifying regulatory risks and crafting mitigation strategies.

Supporting the development of regulatory processes and advising on the impact of regulatory guidance on internal programs.

Assessing change controls related to quality and manufacturing changes to ensure compliance with regulatory standards.

Supporting the creation and maintenance of CMC submission tools and templates to enhance submission efficiency.

Providing interpretation of new regulatory guidance documents, regulations, and directives and advising Manufacturing, Quality, and Process/Analytical Development groups regarding their applicability and impact on internal programs.

**The key Moderna Mindsets you’ll need to succeed in the role**:
**Prioritize the Platform**: You will be crucial in leveraging our technological platforms to accelerate drug development and regulatory approvals.

**Act with Urgency**: The ability to manage multiple projects and navigate a fast-paced environment will be key to maintaining progress and delivering results efficiently.

**Here’s What You’ll Bring to the Table**:
BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required

8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus

5+ years of experience in Biologics focused Regulatory CMC

Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions

Knowledge of current CMC regulations outside of the US, as well, is preferred

Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM)

Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones

Ability to work independently

Exceptional written and oral communication

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

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