Senior Manager, Labeling Operations, Artwork

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’s mission is to establish a leading-edge research development and manufacturing facility at Harwell as part of a long‑term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS and government partners across the UK. We’re looking for global experts eager to join us in this endeavour contributing to a future where access to life‑saving vaccines is a reality for all. This individual‑contributor position is a key opportunity for a forward‑looking regulatory labeling professional to lead the end‑to‑end execution of labeling operations for Moderna’s growing pipeline. Based in Harwell the Senior Manager will manage the generation, modification and submission of global prescribing information and artwork, focusing particularly on Middle East and Asia Pacific markets. The role will interface cross‑functionally with regulatory strategists, project teams and global health authorities to ensure compliance, speed and scientific precision in the delivery of labeling. The Senior Manager will serve as a subject‑matter expert within Global Regulatory Affairs guiding the integration of labeling strategies into Moderna’s broader regulatory submission plans. This role is ideal for someone seeking to shape future regulatory practices and engage with the evolving global labeling environment all while contributing to a mission‑driven biotech at the forefront of innovation. Heres What Youll Be Doing Your key responsibilities will be : Generate and revise prescribing information and regulatory artwork for global submissions with a strategic focus on the Middle East and Asia Pacific regions. Provide subject‑matter expertise in regulatory labeling operations across the product lifecycle ensuring regional compliance and timely execution. Collaborate closely with Regulatory Strategy Leads and Project Teams to align on content requirements and timelines for labeling initiatives. Oversee submission of labeling materials and supporting documentation in accordance with international regulatory agency requirements. Act as regulatory labeling representative on Global Regulatory Affairs Sub‑Teams (GRSTs) contributing operational insight into strategic decisions. Your responsibilities will also include : Support labeling control processes including change implementation and tracking via electronic document management systems. Contribute to the development review and approval of regulatory artwork content as part of cross‑functional regulatory workflows. Assist in gathering documentation for change controls ensuring accuracy and regulatory alignment across all submissions. Maintain strong awareness of evolving regulatory and industry labeling standards sharing insights and influencing best practices internally. Serve as a knowledge bridge between labeling operations and Moderna’s global regulatory infrastructure to ensure high‑quality deliverables. The key Moderna Mindsets youll need to succeed in the role We obsess over learning. We don’t have to be the smartest; we have to learn the fastest. This role sits at the intersection of global regulatory evolution and Moderna’s rapid innovation cycle. Success will require intellectual agility, proactive learning and the ability to incorporate new guidance into global labeling practices quickly and effectively. We digitize everywhere possible using the power of code to maximize our impact on patients. As labeling processes continue to shift toward digital solutions and automation the ideal candidate will embrace digital workflows and contribute to labeling systems that support scale, compliance and rapid delivery to regulators and markets. Heres What Youll Bring to the Table Education Bachelors degree required; Advanced degree preferred Experience At least 5‑8 years of relevant experience in the pharmaceutical industry with preferably 5 years in Regulatory Affairs and specific experience in labeling. Extended knowledge of science and data of assigned products and how that translates into labeling language. Hands‑on assistance with the delivery of labeling for at least one major application (NDA / BLA / MAA / JNDA etc.). Specific skills Experience facilitating meetings and driving consensus and results. Excellent leadership communication (verbal and writing) and collaboration skills. Proven ability in medical / technical writing. Labeling experience (CCDS US EU) in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable. Integrity: overriding commitment to integrity and high standards for self and others. Achievement / Result Orientation: a commitment to working to meet / exceed objectives and deliverables. Strategic orientation: ability to link Moderna’s vision and strategic objectives with daily work. Communication: ability to effectively convey information to a variety of audiences. Specifically interacts effectively as member of the GRSTs and collaborates effectively with business partners including affiliates and third parties. Flexibility / adaptability: ability to adapt to and work effectively within a variety of situations and with various individuals or groups. Relationship building teamwork and cooperation: builds and maintains collaborative relationships with people and demonstrates desire to work well with others. Problem solving: Analytical thinking: understand a situation or complex information by breaking it into small parts to better understand and solve problems. Benefits 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, global recharge days and a discretionary year‑end shutdown 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 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 committed to equal opportunity in employment 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. We consider qualified applicants regardless of criminal histories consistent with legal requirements. We’re focused on attracting, retaining, developing and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds and ideas we create an environment where every employee can contribute their best. Moderna 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. Employment Type Full‑Time Experience Years Vacancy 1 #J-18808-Ljbffr