Role OverviewA seasoned Regulatory Affairs professional will join a pioneering research and development company to develop and implement innovative regulatory strategies for groundbreaking programs.
What You Will Do
Develop and execute global regulatory strategies, lead interactions with global health authorities, prepare briefing packages, and ensure clear communication.
Why It Might Be a Fit
The ideal candidate will have a strong track record of developing regulatory submissions, experience with major approvals, and knowledge of global regulations.
Requirements
- Masters degree in a life science discipline (PhD preferred)
- Minimum of 10 years of regulatory affairs experience in industry, academia, or clinical research
- 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
- Self-motivated, strategic thinker with strong problem-solving skills
- Exceptional organizational and prioritization skills
- Ability to thrive in a fast-paced, collaborative, start-up environment
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