Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer
Job Summary
Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer.
The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging.
Matching Summary
Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer.
Skills & Requirements
Must-have
International product technical files
Global regulatory strategy development
Premarket application review
Product labeling and marketing review
IVDR, UK CA, FDA, Health Canada regulations
Nice-to-have
Strong technical writing skills
Effective communicator
Exceptional attention to detail
Strong organizational skills
Independent self-starter
Work effectively in multinational environments
Key Requirements
Bachelor’s degree or High School Diploma/GED with 5 years experience
7+ years regulated pharmaceutical or medical device experience