Logo

Regulatory Configuration Consultant/Manager - North America

  • LORENZ Life Sciences Group
  • Philadelphia (PA)
  • Published: 2022-05-04
scheme image

Who we are

LORENZ Life Sciences Group is the global market leader for software solutions for digital exchange between the pharmaceutical industry and national and international authorities. Our customers rely on the know-how and commitment of our 120 employees worldwide, who successfully operate at the interface between science and technology on a daily basis. Our products increase the efficiency of the drug approval process and directly contribute to making necessary therapies available more quickly. Help us improve the lives of people who depend on new medicines and therapies!

Your responsibilities

  • Perform software configuration services in North America
  • Review, document and consult customers on their regulatory processes especially related to submission management
  • Work with the sales team to determine the configuration effort for leads in the pipeline
  • Work with the development team to refine a best practice configuration for LORENZ products
  • Providing advice internally as well as to external customers/prospects regarding products, services, and industry trends
  • Manage customer communications with effective written and verbal communication skills  Ensure that project scope and deliverables meet SOW, SLA, MSA requirements

Your profile

  • Bachelor’s Degree in Regulatory Affairs, Computer Science or other related discipline
  • 3+ years of experience in regulatory affairs and regulatory information management, especially document management, submission management, product information/life cycle management
  • Expertise in XML Language is nice to have
  • Prior experience in validation processes and an understanding of validated environments, IQ, OQ and PQ documentation is nice to have
  • Knowledge of LORENZ docuBridge is a plus
  • Strong presentation, public speaking, written communication skills
  • Ability to work independently and remotely

We offer

  • A competitive salary and 401K plan
  • Employee and family health and dental insurance
  • Attractive vacation/holiday schedule
  • Work flexibility/ability to balance work from home office

Your contact in the recruiting process

Ms. Yaprak Eisinger
(Managing Director, North America)
E-Mail: hr@lorenz.cc