Veristat

Director, Regulatory Affairs

Veristat

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $180,000 - $220,000 per year

Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Lead and manage assigned regulatory and cross-functional projects; provide strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products
  • Serve on Veristat multidisciplinary project teams, provide independent regulatory strategy advice, advice on regulatory agency interactions, manage agency communications, lead the preparation of submissions, and create strong rapport with clients
  • Act as a point of escalation for challenging regulatory issues and serve as a mentor and project supervisor to more junior team members
  • Oversee the Regulatory aspects of projects and project teams through the management of internal staff and through interaction with Executive-level staff
  • Responsible for the maintenance of optimal department processes, the implementation of project-specific strategies, and the development and implementation of department strategies to increase productivity and quality
  • Travel up to 25% (Local & International)

Requirements

  • Bachelor’s degree in science, toxicology, pharmacology, engineering or related field; Advanced Scientific degree such as Master’s degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials.
  • 10 years of relevant experience working directly for a CRO/ Pharmaceutical Company, with a minimum 8 years of supervisory experience required.
  • Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
  • Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials are required.
  • In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.
  • Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff.
  • Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
  • Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.
  • Driving/Travel requirements – Travel up to 25% (Local & International)