Experience interacting with fda and ema health authorities
Strong project management and cross-functional collaboration skills
Apogee Therapeutics is seeking a Senior Manager for Regulatory Affairs to oversee regulatory strategies for its biopharmaceutical products. The role demands strong project management and communication skills, as well as regulatory experience in drug development, particularly with interactions with health authorities like the FDA
Job Summary
This newly created role offers an opportunity to work in a fast-paced environment where you help shape the culture and company while overseeing regulatory strategies.
The successful candidate will lead the preparation of documentation for submissions to the FDA and ex-US regulatory agencies including INDs, NDAs, and BLAs.
Apogee Therapeutics offers a competitive compensation package including base salary, performance bonus, equity grants, and three weeks of PTO.
Matching Summary
Match Score: 85
Apogee Therapeutics is seeking a Senior Manager for Regulatory Affairs to oversee regulatory strategies for its biopharmaceutical products. The role demands strong project management and communication skills, as well as regulatory experience in drug development, particularly with interactions with health authorities like the FDA.
Salary
Base: $155,000-$175,000; Bonus/Equity: Performance bonus and equity grant opportunities; Benefits: Health, welfare, retirement benefits, three weeks PTO
Skills & Requirements
Must-have
5 years regulatory experience in drug development
Experience interacting with FDA and EMA health authorities
Strong project management and cross-functional collaboration skills