Senior Manager, Global Regulatory Labeling

at  Moderna

HERE’S WHAT YOU’LL BRING TO THE TABLE:

Bachelor’s degree required; Advanced degree preferred
At least 8+ years of relevant experience in the pharmaceutical industry with preferably 5+ years in Regulatory Affairs and specific experience in labeling
Ability to manage multiple projects in a fast-paced environment and drive them to completion
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
Proven ability to support demanding operations timeline with flexibility without compromising compliance in a challenging environment
Proficiency in Microsoft Office and document management systems
Experience in improving artwork approval processes and systems
Experience in a GMP environment is required
Experience in biotech or pharmaceutical environment is required

SPECIFIC SKILLS:

Experience facilitating meetings and driving consensus and results.
Excellent leadership, communication (verbal and writing) and collaboration skills.
Integrity: overriding commitment to integrity and high standards in self and others.
Achievement or Result Orientation: a concern for working well or for surpassing a standard of excellence.
Strategic orientation: ability to link visions and daily work
Relationship building, teamwork and cooperation: builds or maintains friendly relationship with people and demonstrates desire to work.

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 presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions, meeting the growing demand of Moderna’s global business operations. We’re inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.​
This is a pivotal new position within the Global Regulatory Labeling team, where you will lead and innovate in the packaging and labeling artwork creation, review, and approval processes. This role requires a forward-looking, creative regulatory labeling professional who anticipates and addresses the challenges involved in swiftly delivering container labeling for products to new markets, with a particular focus on the EU, Canada, Australia, Japan, and Latin America.
Here’s What You’ll Do:Your key responsibilities will be:
Developing new artwork and managing these changes through approvals in collaboration with Supply Chain and cross-functional teams including Commercial, Quality Assurance, Regulatory, and Legal.
Overseeing the integration of labeling strategies with broader regulatory and marketing strategies to maximize product impact.

YOUR RESPONSIBILITIES WILL ALSO INCLUDE:

Acting as a liaison to foster relationships within the industry and ensure the adoption of best practices in labeling.
Monitoring industry developments and integrating innovative labeling technologies and processes into Moderna’s practices.
Driving continuous improvement in labeling operations to enhance global compliance and market readiness.

THE KEY MODERNA MINDSETS YOU’LL NEED TO SUCCEED IN THE ROLE:

Prioritize the platform over any single solution.
Pivot fearlessly in the face of new data, adapting to changing conditions with agility.