Clinical Project Manager Director DMPK
ASSOCIATE DIRECTOR/ DIRECTOR, REGULATORY AFFAIRS

BRIS.127

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.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

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

REQUIREMENTS:

ADDITIONAL EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

  • 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 careers@unitybiotechnology.com

Please send resume and cover letter