Director, Regional Regulatory Strategy, Infectious - Basel, Schweiz - Moderna Therapeutics

Moderna Therapeutics

Geprüftes Unternehmen

Basel, Schweiz

vor 2 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

The Role:

The Director, Regional Regulatory Strategist - ID will have the opportunity to lead the regulatory strategy with the European Medicines Agency (EMA), act as the regulatory strategy partner for International countries, and provide regulatory support to the VP, Regulatory Affairs

International. This is a new role intended for a forwardlooking, creative, and agile regulatory Director able to anticipate and address the challenges involved in supporting the interactions with the EMA and other International agencies for messenger RNA therapeutics as a new drug modality.

Here's What You'll Do:

Act as the EMA primary contact point for the assigned program

Develop and contribute to content and format for regulatory submissions and related supplements and amendments, including EMA regulatory documents such as meeting requests, briefing books, DSURs, MAA etc.

Work with VP-RA International and Global Regulatory Teams regarding the development and execution of regulatory strategy in the EU and International countries

Coordinate 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

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)

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

Strong knowledge of current EU and International regulations related to the clinical, and nonclinical 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 both independently and within or leading project teams, committees, etc. to achieve business goals and objectives in a fast-paced environment

Ability to effectively collaborate effectively in a dynamic, cross-functional, matrixed 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,