Associate Director/Director, Regulatory Affairs

The Associate Director/Director of Regulatory Affairs at Tango Therapeutics will be responsible for providing regulatory expertise and guidance to support the development of new cancer therapies. This individual will work closely with development teams to ensure compliance with regulatory requirements and to develop efficient and timely development programs. The role will involve leading US submission work, monitoring the global regulatory environment, and supporting the development of global regulatory strategies. The Associate Director/Director will also provide advice and guidance on relevant regulatory requirements and review processes.

• Provide regulatory expertise for product development including clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance
• Collaborate with CRO and niche providers to support global regulatory filings
• Monitor the regulatory environment globally and assess the impact of new and changing regulations on the company's research and development programs
• 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 provide regulatory advice, filing, and maintenance requirements for the oncology pipeline
• Ensure activities are conducted in compliance with relevant laws, regulations, and guidance, including manufacturing, research, clinical, and quality
• Manage regulatory filings and contribute to regulatory and/or development strategy
• Ensure 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
• Perform additional duties and responsibilities as required

• Bachelor's degree in Biological Sciences, Pharmacy, or related field
• Experience in regulatory affairs, specifically in product development and compliance
• Knowledge of clinical research, CMC, regulatory operations, and nonclinical study requirements
• Familiarity with global regulatory filings and ability to work collaboratively with CRO and niche providers
• Understanding of the regulatory environment and ability to assess the impact of new and changing regulations on research and development programs
• Ability to support global regulatory strategies, including clinical, nonclinical, and CMC aspects
• Strong communication and collaboration skills to provide regulatory advice and support to project teams
• Knowledge of relevant laws, regulations, and guidance in manufacturing, research, clinical, and quality
• Experience managing regulatory filings and contributing to regulatory and/or development strategy
• Ability to interpret and apply relevant regulatory requirements and review processes
• Strong attention to detail and ability to ensure compliance with regulatory requirements
• Flexibility to take on additional duties and responsibilities as required.

• 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