What are the responsibilities and job description for the Global Compliance Director position at Enigma Search?
Your Responsibilities
As our ideal candidate, you will have a Master's degree in a life science discipline and a minimum of 10 years of regulatory affairs experience in industry, academia, or clinical research.
You will be responsible for developing regulatory submissions, including experience with major approvals (NDA, BLA, MAA, etc.), and staying ahead of global regulatory changes.
- Strong knowledge of global regulations (FDA, EMA, etc.).
- Experience with mechanisms to expedite agency interactions.