Associate Director, Global Regulatory Strategy, Infectious Disease, COVID 19 Vac

The Role:Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the COVID-19 franchise to be based in one of Moderna’s US offices. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in gaining and maintaining market approval for messenger RNA vaccines as unprecedented new drug modality in the US and other markets as relevant.The Associate Director will be a strategic leader within the Global Regulatory Strategy, Infectious Diseases group. They will be responsible for developing and executing regulatory plans for at least the US market for assigned programs at any stage of product development. As an expert within Regulatory, they will be relied upon to articulate clear and compelling regulatory strategy and highlighting risks and opportunities when appropriate. Prior regulatory experience with infectious disease & vaccine development preferred.Here’s What You’ll Do:Sets strategic direction for at least the US market, in collaboration and alignment with the global product strategy with GRL, Global Regulatory Sub-Teams and project teams for assigned program(s).Ensures the US regulatory strategy is aligned with the global strategy for assigned program, including for initial marketing application submissions and/or vaccine strain updates.Leads the development of content, format and accountability for regulatory submissions and related supplements and amendments to at least the US FDA, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, DSURs, (s)BLA, etc.Conducts risk assessment and identifies potential areas of regulatory concern for assigned projects or programs and responds to new government/regulatory developments.Responds to requests for additional data, organizes and manages participation in meetings relevant to at least the US market.Reviews and may approve regulatory documents prior to submission to respective regulatory authority(ies).Serves as primary point of contact and negotiates directly and effectively with FDA and other health agencies for assigned programs.May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant.Identify areas in need of improvement and lead the development and implementation of process improvements.Here’s What You’ll Bring to the Table:BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.7+ years of experience in the Pharmaceutical industry preferred.5+ years of experience in Regulatory strategy or relevant training/experience preferred.Experience in Infectious Diseases and/or Biologicals is preferred.Strong knowledge of current US regulations.Strong experience with CTD format and content of regulatory filings.Exceptional written and oral communication.Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance at least in the US.Demonstrate strong organizational skills, including the ability to prioritize workload.Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.Experience in authoring regulatory documents.Knowledge and understanding of applicable regulations.Experience working on products across all stages of product development.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.Moderna is committed to equal employment opportunity 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.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

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