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
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 email@example.com