This is a Regulatory Manager position with a growing biopharmaceutical company focused on advancing their lead product candidate!

The Role:

• Reports to the Senior Director of Regulatory Affairs
• Plays a central role as the internal regulatory expert and point of contact on Clinical Study
• Teams and in coordination across the Regulatory function
• Ability to strengthen working knowledge of US/EU regulatory requirements
• Lead cross-functional teams

Qualifications:

• 5-7 years of experience in an academic/industry clinical research company
• Heavy in cross functional experience
• End Note experience is needed
• Later stage experience
• BA/BS in relevant field

Ideally:

• RAC certification
• Good understanding of Regulator Affairs CMC