Manager, Global Regulatory Science - Basel, Schweiz - Moderna

Moderna

Geprüftes Unternehmen

Basel, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

The Role:

Provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, and maintenance of regulatory databases and archives.

Here's What You'll Do:

Oversees the regulatory submission of CTAs to national HAs world-wide as required: e,g, guides and coordinates the CTA dossier compilation for submission, coordinating operational activities related to M1 (administrative forms filling in; translations coordination; artworks coordination if required etc.) and beyond.

Supports the regulatory Clinical Trial Applications submission activities for allocated clinical trials directly to Health Authorities or facilitating the CTA submission by local personnel in their specific country.

Liaise with and provide oversight to CRO supporting the CTA submissions and query management.

Drives the implementation of the global CTA submission strategy, as well as the quality and extensiveness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.

Oversees the mandatory regulatory requirements are in place to comply with country-specific requirements for CTAs or other regulatory submissions as required.

Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) incl. CRO team representatives to ensure optimal execution of the agreed regulatory strategy for the development of medicinal products

Maintains good knowledge of regulatory requirements and guidelines especially European regulations on Clinical trials, or other upcoming regulatory initiatives as assigned (e.g. regulations or guidance on novel product initial registration or life cycle management).

Communicates and guides cross-functional teams on European regulatory requirements and changes in the regulatory landscape.

Leads process improvement initiatives within GRS or the International HQ as required

Maintains effective archiving and submissions/approvals tracking records, as well as a database of HA questions ensuring learning is consistently captured and disseminated within the company

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 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 e