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Director, Regulatory Affairs

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Title: Director, Regulatory Affairs
Position Type: Permanent
Location: Raleigh/Durham, North Carolina

Brio Resource Group is a search firm committed to providing rare pharmaceutical talent on an executive search basis to the Pharmaceutical, Biopharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging companies. Our many years of experience, subject matter expertise, proven search process and genuine passion to deliver rare talent defines Brio.

Our client is seeking a Director, Regulatory Affairs to support day-to-day management of regulatory operations and regulatory compliance activities in accordance with corporate policies, industry standards, and applicable regulatory requirements.

We welcome the opportunity to provide a full job description upon resume review.

Responsibilities:

  • Responsible for managing the regulatory operations activities for company programs
  • Oversee tracking, document development, publishing, and submission activities for company programs
  • Manage external vendors to support regulatory operations activities
  • Assist QA and other staff with regulatory agency inspections and audit activities

Requirements:

  • Bachelor’s degree and at least 5 years of Regulatory Affairs experience required
  • Strong knowledge of US FDA regulations, ICH guidelines, and GXPs
  • IND submissions management experience required

How To Apply:

Please submit your CV to CV@briogrp.com or click “APPLY. An appropriate member of our executive recruitment team will review your credentials and respond to arrange an initial interview to review your credentials and career objectives.

We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.

Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected statu