Job Summary
A pharmaceutical company is searching for a person to fill their position for a Remote Inflammation US Regulatory Affairs Senior Associate Director in Ridgefield.
Candidates will be responsible for the following:
- Presenting or supporting review of US-specific regulatory topics to Regulatory Expert Group (REG), as appropriate
- Acting as primary company liaison with the US Food and Drug Administration
- Effectively contributing broad range of US operational and strategic perspectives to RA Sub team
Qualifications Include:
- (In-depth) knowledge in RA gained through direct regulatory liaison with US FDA
- Ability to analyze and interpret scientific data and regulatory guidelines
- Critical thinker with ability to self-direct workload, including reprioritizing and delivery under tight timelines
- Bachelor's degree from an accredited institution in life sciences, pharmacy, or chemistry with extensive drug development experience/knowledge
- Excellent meeting preparation and presentation skills
- Excellent oral and written communications skills with the ability to provide key messages in a concise manner
