Director/Senior Director, Regulatory Affairs

Reporting to: VP, Regulatory and Quality Affairs


The Director is a key member contributing to the development and execution of regulatory strategy and execution of Tolero’s innovative oncology-focused pipeline. In addition to preparing and coordinating regulatory submissions, he/she will be an integral team member working closely with Tolero Senior Management to develop and maintain an innovative culture and environment.


Phases I-III Research & Development Activities
  • Supports Tolero in formulation of regulatory strategy and interactions with Health Authorities
  • Assist with preparation, coordination and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments, briefing book for HA meetings) and responses to HA information requests
  • May represent Tolero on less complex project-related meetings and provides regulatory input as appropriate
  • Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
  • Contributes to documentation of Health Authority interactions including decisions and outcomes
  • Provides project updates at the Tolero meetings upon request
  • Effective collaboration with other Tolero departmental efforts
  • Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing


  • B.S. degree, preferably in a scientific discipline
  • 10-15 years’ experience
  • Prior biopharmaceutical industry experience; minimum of 5 years focused in Regulatory Affairs
  • Sense of urgency and perseverance to achieve results
  • Demonstrated ability to operate in a dynamic and fast-paced environment and manage a complex environment
  • Strong verbal, written communication, interpersonal, listening, and organizational skills required
  • Unquestionable ethics, professional integrity, and personal values consistent with Tolero's values
  • Ability to work in a diverse environment
  • Demonstrated ability to adapt to changing priorities and tolerate uncertainty and ambiguity
  • Demonstrated ability to facilitate appropriate team decisions
  • Experience contributing to electronic regulatory submissions and working with regulatory templates
  • Familiarity with medical terminology, FDA and ICH regulations/guidance specific to clinical research and general product development in the pharmaceutical industry

Please send resumes to