Director, Regulatory Affairs

Location
Waltham, MA
Posted
Mar 12, 2018
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time

Company Overview

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.

Job Summary:

Conducts all regulatory activities necessary to support clinical trials, product development and to achieve market approval of drug candidates for assigned projects and is responsible for implementing the strategic plans of all global regulatory strategies in order to achieve the company’s objectives regarding development, approval and marketing of new drugs.  Conducts liaison activities with FDA, and is responsible for ensuring the accuracy and integrity of all documentation supplied for any regulatory submissions for assigned projects.  Some liaison activity with potential partner, EU agents or Authorities may be required per project needs.  Incumbent will be the corporate strategic regulatory representative for assigned projects for communication purposes.

Essential Job Responsibilities:

  • Participates in project team activities to apply regulatory strategy to enable rapid development and commercialization of project candidates and ensure regulatory compliance for all submission to regulatory agencies.
  • Supports the product development and life cycle management efforts of internal project teams for assigned projects.
  • Facilitation and support of clinical activities conduct by or on behalf of Eloxx Pharma
  • Planning, execution and tracking of regulatory submissions to assure that the documentation generated by the project team is complete and adequate for its purpose and is in compliance with the appropriate regulations and guidance documents.  Provides appropriate communications and guidance to the internal functional area (QA, QC, Manufacturing, Process Development, Clinical, Discovery, Research, etc.) responsible for the review of submission documentation.
  • Serves as the primary interface with any external, contracted or outsource regulatory strategic and/or liaison services for assigned projects, such as transmission of regulatory documentation to/from Eloxx Pharma for submission purposes.
  • Assures that any regulatory submissions and/or communications for assigned projects are distributed to senior management and the project team in a timely manner and are appropriately archived within the Regulatory Operations.

Qualifications/Experience:

  • Master degree with 12-15 years of experience in Regulatory Affairs within the pharmaceutical industry
  • Prior success with the submission of marketing applications is a plus. 
  • Ability to travel 30%

Interested candidates can click "Apply now"