Medella Life

Manager Clinical Regulatory Affairs

United States
Experience Based
09 Apr 2021
09 May 2021
Full Time
Contract Type
Experience Level

Your role: The Strategist for Global Regulatory Affairs (GRA) Oncology develops and prepares regulatory strategies for projects. It manages submission and approval of applications for clinical trials (WW) and marketing applications, full submissions and variations in 3 ICH regions. In addition, the role represents the company in external forums and in co-development joint committees. Internally the role works as representative for GRA in Global Project Teams. The role manages the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation. As strategist you will manage the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes. The role manages in addition the Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs and CTD (development and registration status) and leads a GRA sub-team.

Who you are:

  • Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, Degree in pharmacy or medicine)
  • Minimum of 8 years’ industry experience of which at least 6 years’ regulatory experience
  • Experience in preparation and submission of a full submission/or large variation/supplement in at least one ICH region through to authorization
  • Experience with regulatory agency interactions and preparation of documentation to support interactions
  • Experience in NCE and NBE drug development
  • Excellent spoken and written English