Head of Regulatory Affairs

Head of Regulatory AffairsAbout the CompanyPioneering biotech companyIndustryBiotechnologyTypePrivately HeldAbout the RoleThe Company is seeking a Head of Regulatory Affairs to take on a pivotal role in the organization. The successful candidate will be responsible for owning the global regulatory strategy, with a primary focus on preparing and filing INDs. This is a unique opportunity to build the regulatory function from the ground up, including team, systems, processes, and infrastructure. The role requires a leader who can partner cross-functionally with clinical development, CMC, nonclinical, and executive leadership to align development milestones and regulatory pathways. The Head of Regulatory Affairs will also lead interactions with health authorities, drive submission planning and execution, and provide guidance on regulatory risks and decision-making. Applicants for the Head of Regulatory Affairs position at the company should have a minimum of 20 years' experience in regulatory affairs within the biotech or pharma industry, with a proven track record in leading IND filings and early-phase regulatory strategy. A strong background in oncology is essential, and experience in biologics is highly preferred. The ideal candidate will have a demonstrated ability to build regulatory capabilities from the ground up and to lead, influence, and operate effectively in a fast-paced, resource-lean startup environment. A strategic and execution-focused approach, with a builder mentality, is also a key requirement for this role.Travel PercentLess than 10%FunctionsOperations