Title: Associate Director, Regulatory Strategy
Summary: A groundbreaking biotech, world renowned for their RNA therapeutics is seeking an Associate Director, Regulatory Strategy to join their team. The right candidate for this position is innovative, creative, and passionate about the Autoimmune/Rare Disease space. As a strategic leader, this professional will develop and execute regulatory strategy for unprecedented new drugs and various exciting programs.
The Associate Director, Regulatory Strategy will be responsible for:
- Develop and lead regulatory strategy for various programs in the rare disease and autoimmune therapeutic areas
- Leading interactions with health agencies by building and maintain relationships, organizing and participating in meetings, responding to requests, and negotiating various filings.
- Coordinating cross functionally, partnering to develop submission content and communicate regulatory strategy
- Work on various regulatory submissions including INDs, CTAs. ODDs, DSURs, MAA/BLAs.
- Proactively identify potential challenges to regulatory strategy and problem solve.
The Associate Director, Regulatory Strategy should have the following qualifications:
- PharmD, Masters, or PhD preferred, BS/BA required
- 6+ years in Regulatory Strategy or 8+ years in the Biopharma industry with significant Regulatory experience
- Direct experience working with the FDA and regulatory authorities, strong knowledge of US and EU regulations
- Strong experience with various regulatory submissions, with delivery of at least one major application (NDA/BLA/MAA, etc.) and experience with CTD format
If you are interested in the Associate Director, Regulatory Strategy role, then please don't wait to apply.
