Job Title: Regulatory Affairs Manager
Job Number: 24167
Location: Boston, MA
As a member of the Silicon Therapeutics’ Regulatory team, the Regulatory Manager will support programs with major filings (INDs, NDAs, MAAs) and will work collaboratively with cross functional teams to support development milestones. The Regulatory Manager will also be responsible for managing CROs responsible for Ex-US clinical trial applications including driving submission strategies and timelines, reviewing and approving submission components, and working with program teams to create or obtain required submission documents. The Manager will also take a leadership role in establishing internal regulatory tracking systems and archiving systems and developing regulatory SOPs. The ideal candidate will be a motivated self-starter who thrives in a fast-paced, small team dynamic environment.
- Compile and manage regulatory submissions for assigned projects
- Responsible for supporting active INDs and CTAs including planning for and coordinating IND maintenance submissions, managing CROs responsible for clinical trial applications outside of the US and responding to questions
- Support external regulatory consultants, and contribute to the development and implementation of CMC, nonclinical, and clinical regulatory strategies for projects in all stages of development (pre-IND through commercial) for assigned projects
- Support preparation for Health Authority interactions including preparing meeting requests and briefing books
- Responsible for developing or contributing to the development of project timelines and the planning of regulatory milestones
- Contribute to the continuous improvement of existing department processes and strategies
- Maintain regulatory archives and submission trackers
- Contribute to and develop regulatory SOPs
- BS with 5+ years of related experience; MS with 2+ years of experience.
- Demonstrated experience in contributions to early stage filings (IND preferred)
- Strong computer skills, Excel, Word and PowerPoint.