Associate Director, Labeling Operations, Artwork

The Role :Ensure all your application information is up to date and in order before applying for this opportunity.Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.Modernas 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 establishing a significant presence at Harwell the UKs globally recognized science and innovation campus. Were looking for professionals who want to be part of a dynamic cutting-edge environment that integrates science technology and collaboration to support our mission of transforming medicine. Harwell offers a unique opportunity to contribute to our growth while being immersed in a vibrant scientific community.Moderna is seeking an innovative and forward-thinking Associate Director Global Regulatory Labeling Operations to drive the end-to-end development and lifecycle management of global container labeling components. Reporting to the Senior Director of Global Regulatory Labeling Operations you will own and evolve the packaging and labeling artwork creation review and approval process within Global Regulatory Labeling. Your focus will center on launching and maintaining high-quality labeling for global markets including the EU Canada Australia Japan and Latin Americathrough seamless cross-functional collaboration.This individual contributor role offers a unique opportunity to embed labeling excellence early in our evolving infrastructure. Youll help define the framework for future artwork systems build strong bridges with Supply Chain Quality Legal and Regulatory Strategy teams and provide critical support to Modernas global expansion. Your work will be instrumental in enabling rapid and compliant access to mRNA-based medicines across diverse health systems.Heres What Youll Be Doing :Your key responsibilities will be :Leading the development review and approval of packaging and labeling artwork across multiple global markets.Serving as a key liaison with Supply Chain and other functions to ensure timely execution of new artwork development and changes.Driving implementation and ongoing optimization of new artwork management processes and software systems.Ensuring compliance with international regulatory requirements for container labeling through robust procedures and stakeholder communication.Participating in global regulatory sub teams (GRSTs) to ensure labeling is aligned with strategy and submission readiness.Your responsibilities will also include :Acting as the labeling subject matter expert to advise on evolving regional regulations and industry standards.Contributing to the end-to-end labeling control process including tracking and implementing updates to existing components.Collaborating with Commercial QA Legal and Regulatory Strategy teams to maintain a harmonized and agile labeling process.Supporting readiness and inspection activities by maintaining documentation and systems to meet health authority expectations.Engaging with external industry peers to bring in best practices and advocate for modern regulatory labeling approaches.The key Moderna Mindsets youll need to succeed in the role :We digitize everywhere possible using the power of code to maximize our impact on patients.This role will lead the implementation of new artwork software solutions and process automation to modernize the labeling lifecycle enabling Moderna to bring therapies to patients faster and more compliantly.We obsess over learning. We dont have to be the smartestwe have to learn the fastest.Global labeling is constantly evolving. Success in this role depends on staying ahead of global regulatory changes adopting new technologies and sharing learnings across teams to strengthen Modernas worldwide impact.Heres What Youll Bring to the Table :Education :Bachelors degree required; Advanced degree preferredExperience :At least 7-10 years of relevant experience in the pharmaceutical industry with preferably 6years in Regulatory Affairs and specific experience in labelingAbility to manage multiple projects in a fast-paced environment and drive them to completionAbility to collaborate effectively in a dynamic cross-functional matrix environmentProven ability to flexibly support demanding operations timelines without compromising compliance in a challenging environmentProficiency in Microsoft Office and document management systemsExperience with artwork approval processes and systems continuous improvementExperience in a GMP environment is requiredExperience in biotech or pharmaceutical environment is requiredSpecific skills :Experience facilitating meetings and driving consensus and resultsExcellent leadership communication (verbal and writing) and collaboration skillsIntegrity :overriding commitment to integrity and high standards for self and othersAchievement / Result Orientation :a commitment to working to meet / exceed objectives and deliverablesStrategic orientation :ability to link company and departmental visions with daily workRelationship building teamwork and cooperation :build and maintain strong working relationships with colleaguesProblem solving :Analytical thinking :understand a situation or complex information by breaking it into small parts to better understand and solve problemsBenefits :Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness nutrition and mindfulness classesFamily planning and adoption benefitsGenerous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdownSavingsandinvestmentsLocation-specific perks and extrasThe benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.About ModernaSince our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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.As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70 / 30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.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 applyEqual Opportunity StatementModerna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons 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. We consider qualified applicants regardless of criminal histories consistent with legal requirements. xpwpeyx AccommodationsModerna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and / or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .#LI-JP1Required Experience :DirectorKey SkillsBusinessInformation ManagementAccountingCorporate Risk ManagementFacultyJmsEmployment Type :Full-TimeExperience :yearsVacancy :1#J-18808-Ljbffr