Director, Regulatory Science

vor 6 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.

An exciting opportunity has arisen for an experienced and dynamic Emerging Markets (EM) RA Strategy Lead to join our team. In this pivotal role, you will be responsible for developing and communicating the regulatory strategy for assigned projects within Emerging Markets. This will include designing and assessing regulatory strategy options on a regional/global basis in close collaboration with local RA teams.

**Here's What You’ll Do**:Your key responsibilities will be**:
Leading core EM dossier preparation and compilation efforts.

Representing RA at relevant meetings and presenting agreed RA positions, negotiating with and influencing management across various functions to ensure regulatory compliance and program success.

**Your responsibilities will also include**:
Working closely with the VP-RA EM and Global Regulatory Teams to develop and execute regulatory strategies in EM countries.

Participating as a core member of the relevant Global Regulatory Sub-Team (GRST).

Harmonizing new registration and regulatory processes across EM countries to improve efficiency and capacity.

Providing strategic regulatory guidance for assigned projects and managing key stakeholder relationships.

**The key Moderna Mindsets you’ll need to succeed in the role**:
**Pursue options in parallel**: You will be adept at managing multiple strategies and options simultaneously to ensure the most effective outcomes.

**Prioritize the platform**: Your focus on the broader goals and the ability to prioritize tasks will be crucial in driving the success of our vaccine programs across diverse markets.

**Here’s What You’ll Bring to the Table**:
Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)

12+ years of experience in the pharmaceutical industry. 7+ years of experience in Regulatory strategy

Extensive experience in working with Emerging Markets region, including leadership experience at a senior level; this should include experience in regional or global level role

Combined knowledge of scientific, regulatory and business issues to develop vaccines to meet required global, regional and local regulatory requirements

Ability to network effectively, internally and externally to develop productive working relationships with key stakeholders, managing and influencing across a matrix

Experience in an International environment/developing countries, exposure to and understanding of the regulatory environments in the EU and USA are required

Sound understanding of regulatory systems, requirements processes to ensure knowledgeable discussion with internal and external stakeholders

Cultural awareness as the role covers markets spanning Africa, Middle East, LATAM and Asia

Strategic thinking, understanding of Moderna’s business and the external environmental factors that shape/drive the industry. Develop strategies to maximize outcomes for Moderna

Effective execution of agreed strategies and able to adapt these to reflect changing conditions while still delivering required end results

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

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