Who We Are
Ashvattha Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel hydroxyl dendrimer (HD) therapeutics (HDTs) to treat unmet medical needs in oncology, ophthalmology, and inflammatory diseases. We believe that HDTs will become the future of targeted therapeutics and unlock new levels of patient care.
The Role
The successful candidate will be responsible for the development and execution of an effective global regulatory strategy for our products including clinical, nonclinical and CMC aspects. The individual must not only be adept at formulating and driving strategy, but also be tactically oriented, preparing and writing submissions and playing a hands-on role in regulatory submissions. Lead all communications and submissions with regulatory agencies (including X-US), continuing for the entire product development life cycle. Using your in-depth expertise as a regulatory affair professional, act as an internal consultant providing colleagues with strategic leadership and key insights that will allow the organization to operate collaboratively and proactively. Initially, this will be an individual contributor position with the opportunity to build a team and the potential for promotion to a VP.
Key Deliverables
Establish regulatory approval strategy in US and ex-US for global Phase 2 OP-101 study (ongoing) in severe COVID-19 patients; Lead OP-101 EOP2 meeting with FDA and other regulatory authorities in Q3 2022; Lead filing of US IND on D-4517.2 (current in Phase 1 in Australia) in Q1 2022; Lead discussions with Neurology Division of FDA on use of OP-801 in combination with OP-101 in ALS patients (IND for OP-801 targeted for end Dec 2021); Work with program management and clinical to develop global regulatory strategy for D-4517.2 and OP-801; Support manufacturing submissions for process scale-up to 10 kg by end of 2022
Skills/Expertise Required
B.S. degree in a related discipline. Extensive regulatory experience including IND/NDA/BLA, lifecycle management, labeling, interactions with Health Authorities, and experience in developing short- and long-term regulatory strategies to rapidly deliver innovative products to the market. Led or been a significant contributor to regulatory filings that resulted in approval of a drug. Expertise in building and leading a team of multi-disciplinary regulatory affairs professionals. Broad blend of experience in Regulatory Affairs and must have worked directly with FDA and other international agencies on regulatory matters. Recent filing experience globally, U.S. and European regulatory authorities required, experience with Asia / Pacific region a plus. Deep familiarity with the overall drug development process especially related to clinical trial requirements for submissions required
In order to enhance collaboration and communication, we require employees to work on site at our Redwood City facility at least 2-3 days per week.