Director, Regulatory Affairs, Regional Regulatory

**The Role**:
**Here's What You’ll Do**:
Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including EMA regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs, MAA etc.)

Work with the International local regulatory leads in Canada, Asia, Latin America etc. and Global Regulatory Teams regarding the development and execution of regulatory strategy in the EU and International countries and regions

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 business goals and objectives

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

**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. 10+ 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

Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant

Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Fluency in English is required. The knowledge of other European languages is a plus.

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.

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.

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