Manager, 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.
This position is responsible for the management of regulatory operations for the development of electronic publishing for both report level, new drug applications, and marketing authorization applications. Duties also include coordinating activities of submission projects, managing the logistical details associated with generating electronic regulatory submissions. Ensures accurate, timely workflow of electronic documents into the publishing structure. Works with project teams regarding electronic publishing, ensuring conformance to timelines and adherence to company publishing standards and applicable agency regulations.
Essential Job Responsibilities
- Coordinate and prepare publishing activities of all domestic and international regulatory filings in compliance with regulatory agency guidelines.
- Interface with project and regulatory managers, department authors and external sources to coordinate and effectively compile and assemble content for domestic and international regulatory filings.
- Contribute to design, development and implementation strategies for dossier management and planning.
- Advises regulatory staff and product teams on format and layout of documents.
- Support and promote developing electronic initiatives to move forward with electronic submissions.
- Responsible for supporting publishing activities associated with generating quality hard copy and electronic regulatory filings.
- Apply quality control processes to ensure document integrity for electronic document collection, storage, retrieval and archive.
- Oversees the design, development, tracking and reporting of regulatory submissions, agency correspondence and other pertinent documents utilizing the submission tracking database.
- Bachelor’s degree in a scientific discipline
- 8-10 years of experience in the pharma industry
- Prior success with the submission of marketing applications is a plus.
- Ability to travel 30%
Interested candidates can