What are the responsibilities and job description for the Global Regulatory Lead position at Enigma Search?
Our company is seeking an experienced Director of Regulatory Affairs to lead the development and implementation of regulatory strategies for our life-changing programs.
The ideal candidate will have a proven track record of developing regulatory submissions, including experience with major approvals (NDA, BLA, MAA, etc.).
Key Responsibilities:
- Develop and execute global regulatory strategies for assigned programs.
- 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.
- Oversee the preparation and submission of regulatory applications, ensuring accuracy and timeliness.
Requirements:
- 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.
- 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.
