Sr. Manager, Regulatory Strategy

The Role:Moderna Therapeutics is seeking a Sr. Manager of Regulatory Strategy based in Cambridge headquarters. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as unprecedented new drug modality. The Sr. Manager will provide regulatory support for Oncology. Their support includes but is not limited to managing the submissions and approvals of INDs, marketing applications, and other regulatory submissions (orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.)Here’s What You’ll Do:Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.)Works with RA-Strategist and project teams regarding the development and execution of regulatory strategy through the clinical development processes.Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs.Contact regulatory agencies relevant to assigned projects or programs, as appropriate.Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).Contribute, maintain the Core Data Sheet and support global labeling team meetings.Ability to work both independently and within project teams, committees, etc. to achieve group goals.Here’s What You’ll Be Doing:BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.5+ years of experience in the Pharmaceutical industry preferred3+ years of experience in Regulatory strategy or relevant training/experience preferredExperience in Oncology is strongly preferredStrong knowledge of current US and EU regulationsStrong experience with CTD format and content of regulatory filingsExceptional written and oral communicationExperience with developing and implementing gap analysis and related competitive regulatory strategiesKnowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EUDemonstrate strong organizational skills, including the ability to prioritize workload.Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.Knowledge and understanding of applicable regulations.Experience in interpretation of regulations, guidelines, policy statements, etc.Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.About ModernaSince 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.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.

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