The Opportunity:

We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to ​help define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the regulatory representative on relevant project teams ​and where applicable, you will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions.

Your Role: 

• You will work with our Head of Regulatory Affairs/Global Regulatory Lead and your research and development colleagues to develop​ and execute innovative regulatory strategies for our development programs, including supporting the implementation of non-clinical and clinical regulatory strategy for relevant products.
• You will be responsible for managing the preparation and submission of high quality domestic and global regulatory submission documents (i.e. IND, CTA, NDA/MAA), as well as the development of response strategies to regulators, including liaising with regulatory operations to support submissions.
• You will be responsible for communicating with the global regulatory authorities and support the preparation and conduct of meetings with health authorities, which includes supporting the development of robust briefing packages and comprehensive meeting preparation materials.
• You will be responsible for interpreting and communicating regulatory guidance to internal stakeholders to execute program objectives in compliance with applicable regulations.
• You will support the efforts to plan and obtain ​regulatory designations including but not limited to breakthrough therapy designations, fast-track designations, and orphan drug designations and contribute to the CDx strategy development and submissions.
• You will provide oversight to the global regulatory activities ​that are performed by our Clinical Research Organization (CROs) and regulatory vendors.
• Assist in the management and maintenance of the regulatory information management system (RIMS)

Your Background: 

• You have earned your B.S and/or M.S. and bring at least 3-4 years of increasing responsibility in regulatory affairs. Advanced degree or education in a scientific field is a plus.
• You are results-oriented and have experience in managing the preparation and submission of regulatory submissions (IND, CTA, NDA/MAA, etc.)
• Experience in precision oncology, rare disease​ and/or companion diagnostic (CDx) is a plus.
• You are a regulatory interpreter; you have experience in interpretation of regulations, guidelines, and policy statements and know how best to exercise regulatory flexibility.
• You have strong verbal and written communication skills, including the ability to present strategic topics/issues to project teams, management and regulatory agencies.
• Self-motivated and driven with a proactive and flexible working style with a passion for impacting patient's lives through regulatory work.