Associate Director, Regulatory Affairs
Company: Larimar Therapeutics
Location: Philadelphia
Posted on: January 27, 2023
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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
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