Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients, and families impacted by fibrotic diseases.
The Director of Regulatory Affairs and Quality Project Management must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, effective, and efficient. This person will be responsible for managing regulatory milestones from early-stage research through clinical development to registration and will have additional responsibilities supporting the Quality function in developing quality metrics and tracking quality-related activities.
This position serves as an essential partner to both the regulatory strategists and quality team members. This position will be instrumental in helping to drive the global filings into seamless executions and will also serve as a liaison between Regulatory Affairs and Quality team members and other key development functions.
To be successful in this role, you must be able to provide clear direction, communicate clearly (in verbal and written form), and display exemplary organizational and leadership skills. This person must have the ability to develop important relationships with key stakeholders, analyze issues to support relevant and realistic plans, and support program recommendations.
This position will report to the Senior Director of Regulatory Affairs.
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
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