(Sr.) Director, Regulatory Affairs

Posted on July 26, 2016

Overview

Description

Edison Pharmaceuticals is building the world’s leading biological energy company. We are developing laboratory tests and first-in-class drugs for the diagnosis and treatment of diseases of energy dysregulation. We are seeking a Director of Regulatory Affairs with greater than 15-years industry experience in overseeing the development of first-in-class drugs with first-in-class mechanisms for both pediatric and adult clinical indications. The incumbent of this hands-on position will be responsible for helping to develop and implement the company’s overall regulatory strategy to achieve marketing approvals. In addition, the Director of Regulatory Affairs will assist in the development of laboratory-based biomarkers for use clinically and commercially.

Interdependencies:

This position is interdependent with the following R&D groups:

  • Clinical Science: collaboration with Edison’s clinical science team on protocol development, regulatory document preparation and clinical data reports
  • Clinical Operations: collaboration with Edison’s clinical operations team on oversight of clinical trial conduct, and clinical trial monitoring
  • Pharmacovigilance: collaboration with Edison’s PV team for development of regulatory safety reports as well as safety reporting responsibilities
  • Chemistry, Manufacturing and Controls: Collaborate with Edison’s CMC team to develop compliant manufacturing processes and assist in preparation of PAIs
  • Quality: Collaborate with Edison’s QAU to maintain compliant Quality Systems
  • Analytical Chemistry: collaboration with Edison’s analytical chemistry team for development and implementation of regulatory compliant biomarker tests for clinical and commercial use
  • Nonclinical Development: collaboration with Edison’s nonclinical group for generation of regulatory documents including INDs and NDAs

Please reference Job# 16012

Qualifications

Essential Experience
  • MD/PhD/JD with 15+ years experience in biotechnology and/or pharmaceutical industry
  • Track record of successful drug approvals in US and EU with emphasis on rare and pediatric diseases
  • Strategic thinker with proven ability to collaborate with FDA/EMA on non-standard regulatory pathway
  • Experience with regulatory submissions (IND, IMPD, CTA,NDA, MAA) and regulatory compliance reporting
  • Experience in advancing lab diagnostics for clinical and commercial use with understanding of CLIA
  • Consummate team player with hands-on participation

Personal

Apply Now

To apply for this position, please complete the following form and attach your CV.


Upload your Resume
Select fileChange Remove
Upload your cover letter
Select fileChange Remove