Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.
The Regulatory Affairs Lead, under general guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA, EMA and other health authorities within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions may include INDs/CTAs, amendments, annual reports, DSURs, briefing documents, orphan drug applications, and additional documents as needed. He or she will interact effectively with cross functional team members in order to coordinate documentation required for submissions, ensuring timelines are met, have direct interaction with regulatory agencies on defined matters, and contribute to development of regulatory strategy.