Associate Director, Global Regulatory Science, CMC

The Role: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 solidifying its presence in Harwell a global hub for scientific advancement in the UK. Our Harwell office will be home to roles critical to our mission of delivering mRNA medicines to patients worldwide. Join us at this exciting location where youll help shape the future of healthcare innovation in one of the UKs most dynamic science and technology campuses.This role is central to Modernas global regulatory success. As Associate Director Global Regulatory Science CMC you will lead regulatory CMC strategy and execution for one or more mRNA programs. You will be instrumental in developing global strategies and ensuring that regulatory submissions are flawlessly executed across the product lifecycle including pre- and post-approval phases. Youll collaborate closely with Manufacturing Quality and Analytical Development groups to guide regulatory compliance and shape submissions that meet both scientific rigor and business needs. Youll also be responsible for preparing key regulatory documents and leading Health Authority interactions. This role requires a technically strong action-oriented leader who thrives in fast-paced environments and is eager to contribute to Modernas transformative impact on patient care through mRNA technology.Heres What Youll Do:Your key responsibilities will be:Developing and implementing regulatory CMC strategies for global IND/CTA/BLA/MAA submissions covering both new applications and post-approval filings.Leading regulatory CMC input for quality and manufacturing activities with a focus on risk identification and mitigation.Preparing and overseeing the submission of CMC and Quality-related documents to global Health Authorities.Driving Health Authority interactions and ensuring alignment between internal teams and external expectations.Guiding stakeholders on regulatory implications of changes to process manufacturing or analytical controls.Your responsibilities will also include:Reviewing submission documents for readiness ensuring compliance with global regulatory standards.Advising Quality Manufacturing and Development teams on regulatory directives guidance and emerging changes.Participating in the design and upkeep of regulatory tools processes and CMC submission templates.Assessing and interpreting change controls for regulatory impact.Supporting cross-functional collaboration and embedding a global regulatory mindset into CMC initiatives.The key Moderna Mindsets youll need to succeed in the role:We obsess over learning. We dont have to be the smartest we have to learn the fastest.You will operate at the cutting edge of regulatory science navigating global regulatory environments while rapidly absorbing emerging CMC guidance and translating it into actionable strategy.We digitize everywhere possible using the power of code to maximize our impact on patients.Your work will be amplified by digital tools and data-driven systems. Embracing Modernas commitment to digital innovation youll contribute to modernizing regulatory operations while staying close to breakthroughs in Generative AI.Heres What Youll Bring to the Table:BS/MS/PhD in Molecular Biology Pharmaceutics Chemistry Chemical Engineering or closely related field is required8 years of experience in the pharmaceutical/biotech industry manufacturing and/or analytical focus5 years of experience in Biologics- and/or Vaccines-focused Regulatory CMCDirect experience and strong knowledge of current global CMC regulations including CTD format and content of CMC regulatory submissionsKnowledge of and broad experience with regulatory procedures related to CMC aspects of drug development product registration and post-approval lifecycle management (LCM)Ability to effectively collaborate in a dynamic cross-functional matrix environment to meet critical regulatory milestonesAbility to work independentlyExceptional written and oral communicationAs part of Modernas commitment to workplace safety this role may require an enhanced pre-employment check.At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work at home and everywhere in between.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 applyModerna 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.Were 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 at .-Required Experience:Director Key Skills Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation Employment Type : Full-Time Experience: years Vacancy: 1