What are the responsibilities and job description for the Director of Compliance and Regulatory Strategy position at Enigma Search?
We are searching for a highly skilled Director of Regulatory Affairs to join our Enigma Search team and drive regulatory success from IND-enabling studies through clinical proof-of-concept and beyond.
The successful candidate will have a strong background in regulatory affairs, with experience in developing and executing global regulatory strategies for assigned programs.
Main Objectives:
- Develop and execute global regulatory strategies for assigned programs, including first-in-class therapies and programs with external partnerships.
- Lead interactions with global health authorities, preparing briefing packages and ensuring clear communication.
- Collaborate with executive leadership to define regulatory strategies aligned with the company's mission.
About You:
- Master's degree in a life science discipline (PhD preferred).
- Minimum of 10 years of regulatory affairs experience in industry, academia, or clinical research, with experience in rare disease development and/or novel endpoints.
- Proven track record of developing regulatory submissions, including experience with major approvals (NDA, BLA, MAA, etc.).
- Strong knowledge of global regulations (FDA, EMA, etc.).
- Experience with mechanisms to expedite agency interactions.
- Advanced skills in creating and assessing regulatory proposals and leading health authority interactions.
- Excellent communication and influencing skills.
