Associate Director/Director
Regulatory Affairs
Posted on 1/12/2023
INACTIVE
Tango Therapeutics

51-200 employees

Develops targeted cancer therapies using synthetic lethality
Company Overview
Tango Therapeutics, a biotechnology firm, stands out due to its unique approach to cancer treatment, utilizing advances in DNA sequencing and CRISPR-based target discovery to develop novel medicines targeting cancer vulnerabilities. The company's focus on synthetic lethality, a method that targets specific genes in cancer cells leaving normal cells largely unaffected, offers a potential for enhanced anti-tumor efficacy and reduced toxicity. Furthermore, Tango's patient-centric approach and deep understanding of genetic subtypes of cancer enable it to identify novel drug targets and combinations, accelerating the development of transformational new therapies for patients with well-defined populations currently lacking effective treatment options.
Data & Analytics
Biotechnology

Company Stage

N/A

Total Funding

$537M

Founded

2017

Headquarters

Boston, Massachusetts

Growth & Insights
Headcount

6 month growth

12%

1 year growth

26%

2 year growth

51%
Locations
Dorchester, Boston, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • 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
Responsibilities
  • 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