Clinical Project Manager Director DMPK


UNITY Biotechnology, Inc (UNITY) is a privately held development-stage biopharmaceutical company focused on developing innovative pharmaceutical therapies that dramatically increase human health-span.  We are located in the San Francisco Bay Area and are seeking to hire an experienced and highly motivated Associate Director/Director of Regulatory Affairs.

The Associate Director/Director of Regulatory Affairs will be responsible for the development and execution of global regulatory strategies leading to the successful development, registration, and life-cycle management of novel therapeutic agents aimed at modifying diseases and improving the health span of patients suffering from age-associated illnesses. The individual is expected to exhibit strong project leadership, values and creativity.


These may include, but are not limited to:

  • Represent regulatory affairs as the primary contact on the cross-functional project team; Provide regulatory guidance/strategy/perspective in team meetings
  • Lead the development and execution of global regulatory objectives, strategies and plans for assigned projects
  • Lead and participate in the planning, construction and execution of regulatory submissions; Interact efficiently and independently with cross-functional team members to ensure timely submissions
  • Develop and maintain relationships with FDA review staff; Lead/Assist with the management and conduct of regulatory authority interactions; assure interactions are focused to meet company objectives
  • Communicate regulatory project updates to internal stakeholders across the organization
  • Track regulatory commitments and deliverables
  • Appropriately communicate and apply new regulatory requirements and legislation in a timely manner
  • Assist with development and implementation of internal policies and procedures relating to all aspects of the Regulatory Affairs functions
  • Maintain all regulatory files in compliant manner



  • Bachelor’s degree with at least 5-8+ years of increasing responsibility in the pharmaceutical or related industry; Advanced degree, RAC, or education in a scientific field strongly preferred
  • Highly motivated, results-oriented, collaborative individual with an ownership mentality
  • Advanced problem-solving skills and ability to think creatively and apply innovative solutions to achieve company objectives
  • Demonstrated leadership and participation with U.S. and international submissions, a working knowledge of FDA/EMA regulations, the regulators, and the approval process, and an excellent track record in building effective relationships with regulatory authorities.
  • Additional experience in a small to mid-size, biotech company is a plus
  • Excellent communication skills a must
  • Effective negotiation and decision-making skills
  • Ability to travel ~20%, as needed to support company objectives
  • Sound computer skills: proficient in MS Office and able to learn new systems and train others. Highly competent in an electronic environment

Please send resume and cover letter to

Please send resume and cover letter