Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.
Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.
This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.
The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts
The Associate Director/Director of Regulatory Affairs will be first in role and will report directly to the Head of Development Operations. This individual will provide tactical advice and input into strategy to development teams to achieve efficient and timely development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. This role will lead US submission work.
- You will provide regulatory expertise for product development including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements and regulatory compliance
- Work collaboratively with CRO and niche providers to support global regulatory filings
- Monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's research and development programs
- Together with the development management team, support competitive and effective global regulatory strategies including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
- Attend project team meetings to support team with regulatory advice, filing and maintenance requirements for oncology pipeline
- Ensure that activities are conducted in compliance with relevant laws, regulations, and guidance including with manufacturing, research, clinical, and quality
- Manage regulatory filings and contributor to regulatory and/or development strategy
- Ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements
- Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes
- Additional duties and responsibilities as required
What You Bring:
- Bachelor’s degree in Biological Sciences, Pharmacy or related field is required; Advanced degree or certificate in regulatory affairs is preferred
- Minimum of 6 years of direct regulatory experience in pharmaceutical or biotechnology industry is required
- Early drug submission experience is required
- Oncology experience is required
- Solid working knowledge of the drug development process and regulatory requirements in the US is required with global experience preferred
- Excellent time management skills and ability to work effectively in a fast-paced environment where timelines and protocols must be met
- Proficiency and familiarity with databases or other information management regulatory tools
- Excellent organizational and project management skills to frequently coordinate complex activities, often with competing priorities
- Well-developed analytical skills and the ability to pay particular attention to details
- Well-developed written and oral communication and interpersonal skills to frequently collaborate with other team members
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.