Senior Associate/ Manager, Regulatory Affairs

Pliant Therapeutics is a clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases.  The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The company’s lead product candidate, PLN-74809, is designed to be a selective inhibitor of αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Pliant’s second product candidate, PLN-1474, is designed to be an oral, small molecule selective inhibitor of αvβ1, targeting late-stage liver fibrosis and is partnered with Novartis.   The Company is seeking passionate, creative and dedicated individuals to join our team and contribute to our mission.

Description

Pliant is seeking a passionate and dedicated regulatory professional to contribute to the Company’s mission of helping patients with life-threatening fibrotic diseases. The position will report to the Head of Regulatory Affairs and will lead the planning and compilation of global regulatory submissions and provide clinical trial support for Pliant’s development programs.

Essential Responsibilities

  • Lead the planning, compilation, and timely submission of regulatory deliverables in accordance with applicable regulations, including initial IND applications and amendments and international equivalents as well as routine submissions such as annual reports etc.
  • Representing the Regulatory Affairs function on assigned cross-functional project teams and with external vendors
  • Manage the regulatory sub-team meetings and lead meetings with regulatory objectives
  • Assist in coordinating meeting with Regulatory Authorities and associated briefing document preparation
  • Researching and interpreting global regulations to support regulatory objectives and deliverables
  • Proactively identify and communicate potential regulatory issues/risks and recommend solutions to cross-functional and regulatory affairs team
  • Manage regulatory document management systems to ensure archiving and tracking of regulatory deliverables

Requirements

  • Bachelor’s degree in a scientific discipline required, advanced degree preferred
  • Minimum of 2-3 years in Regulatory Affairs or related pharmaceutical or biopharmaceutical industry experience
  • Experience in management and submission of clinical/nonclinical global regulatory documents
  • Experience and knowledge in preparation of initial INDs and amendments preferred
  • Experience in participating and representing Regulatory Affairs on clinical study management teams preferred
  • Experience with regulatory document management systems
  • Working knowledge of FDA, EMA and ICH regulatory guidance and regulations
  • Strong collaboration and cross-functional team participation skills
  • High self-awareness and commitment to iterative learning and development
  • Effective communicator, verbal and written, strong interpersonal skills with the ability to communicated cross-functionally in a collaborative manner
  • Commitment to accuracy and attention to detail
  • Ability to operate in alignment with Pliant’s Values