Vice President, Regulatory Affairs
Eloxx Pharmaceuticals, Inc. (http://www.eloxxpharma.com/) is a clinical-stage biopharmaceutical company developing novel small molecule medicines to treat many rare and ultra-rare genetic diseases caused by nonsense mutations. Nonsense mutations are a class of genetic defects that result in premature termination of protein synthesis. These nonsense mutations have been identified in over 2,000 rare and ultra-rare diseases. As a consequence, patients with a genetic disease caused by nonsense mutations have absent or truncated nonfunctional proteins, accounting for some of the most severe phenotypes in these genetic diseases. Eloxx’s lead product candidate, ELX-02, is an investigational, novel translational read-through inducing drug designed to restore synthesis of full-length functional proteins. ELX-02 is an investigational agent undergoing clinical trials and has not been approved by any global regulatory body. Eloxx was founded in 2013 and is headquartered in Waltham, MA. with R&D operations in Rehovot, Israel.
This is an opportunity to join a growing and energetic team, build a high performing company, gain personal development and transform patient lives.
Develop and implement regulatory and related strategies for the development and commercialization products. Ensure adequate planning and accurate data for earliest possible approvals of products, taking into account both U.S. and international regulatory requirements.
Essential Job Responsibilities:
- Develops content and format for regulatory submissions, such as INDs (Investigational New Drugs), BLAs (Biologic License Applications), NDAs (New Drug Applications), and related supplements and amendments.
- Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings.
- Reviews and approves technical data and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
- Develops, implements, and reviews current policies and practices issued by Federal and international regulatory agencies.
- Serves as regulatory affairs representative on assigned teams to provide input on phase I, II, and III filing activities and to ensure that report systems are maintained.
- Master's degree with 15-20 years of experience within the biotechnology/pharmaceutical industry
- Experience leading regulatory efforts through the NDA process with a successful track record of gaining drug approvals with the FDA
- Experience working with the BoD would be preferred
- Ability to travel 30%
Interested candidates can click "Apply now"