Sr. Manager, Regulatory Strategy - Oncology

Company: Moderna Therapeutics
Location: Somerville
Posted on: June 24, 2022

Job Description:

The Role:Moderna Therapeutics is seeking a Manager/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 Manager/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.)Heres What Youll 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.Heres What Youll 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.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including: Vacation, sick time and holidays Volunteer time to participate within your community Discretionary winter shut down Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.About ModernaIn over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit .Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. #LI-JM2-SummaryLocation: Cambridge, Massachusetts; Clinical DevelopmentType: Full time

Keywords: Moderna Therapeutics, Somerville , Sr. Manager, Regulatory Strategy - Oncology, Executive , Somerville, Massachusetts