Associate Director, Regulatory Affairs

Company: Larimar Therapeutics
Location: Philadelphia
Posted on: January 27, 2023

Job Description:

Description:Larimar is seeking a Regulatory Affairs Associate Director to support the global regulatory strategy and regulatory activities for products in development. The Regulatory Affairs Associate Director will be a key member of project teams. The role reports to the Regulatory Affairs Senior Director.Job Duties/Responsibilities:Interface with other Larimar departments and outside consultants to obtain timely regulatory deliverables and ensure regulatory complianceAdvise other departments on regulatory health authority requirements for product development and regulatory submissionsPlan, author and review high quality regulatory submissionsMay serve as back up to Regulatory Operations for filing regulatory submissionsMaintain ongoing awareness of global regulations and guidelines relevant to projects Develop internal regulatory procedures and practices Requirements:Minimum of 4-year undergraduate degree8+ years experience in a Regulatory Affairs role in the pharmaceutical industryUnderstanding of GxP systems and Quality principlesAbility to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies.Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissionsExperience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions and Health Authority Meeting packages and marketing authorization applications.Excellent communication, time management and project management skillsContinuous quality improvement mindset and attention to detailsCan do attitude, flexibility, and mental agilityPI200806156

Keywords: Larimar Therapeutics, Philadelphia , Associate Director, Regulatory Affairs, Executive , Philadelphia, Pennsylvania