Head of Regulatory Compliance

4 weeks ago


Florida, United States Barrington James Full time

Position Overview

Our client, Barrington James, is in search of a seasoned Director of Regulatory Affairs to spearhead the development and execution of regulatory strategies for generic pharmaceutical products.

Key Responsibilities

  • Oversee regulatory communications within the United States and with European regulatory bodies.
  • Act as the main point of contact for regulatory agencies.
  • Possess a comprehensive understanding of the intricacies associated with inhaled drug-device combinations.

Required Qualifications

  • A minimum of 7 years of experience in regulatory affairs within the pharmaceutical sector.
  • Experience with ANDA submissions and product labeling.
  • Thorough knowledge of OGD regulatory standards and requirements.
  • Expertise in the complexities of inhaled drug-device products.


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