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Regulatory Affairs Specialist

2 months ago

Massachusetts, United States Meet Full time

Position Overview:

This position is pivotal in steering the strategic and operational dimensions of Regulatory Affairs and Quality Assurance within clinical trials and product approvals. The key responsibilities encompass:

  • Strategic Oversight: Formulate and direct regulatory strategies, conduct risk evaluations, and manage critical issues effectively.
  • Leadership Development: Assemble and guide a high-achieving regulatory team, focusing on recruitment and mentorship.
  • Regulatory Engagement: Represent the organization in discussions with regulatory bodies and oversee submission processes (e.g., IND, CTA, BLA, MAA).
  • Regulatory Expertise: Tackle intricate scientific and regulatory challenges, ensuring compliance with both US and international standards.
  • Quality Assurance: Supervise quality management frameworks and guarantee adherence to regulations, including GCP, GVP, and GLP protocols.

Qualifications:

  • Educational Background: A BS/MS degree is mandatory; a PhD or MD is highly desirable.
  • Professional Experience: A minimum of 15 years in Regulatory Affairs and Quality Assurance, with over 10 years in leadership capacities. Extensive experience with biologics and BLA/MAA submissions is crucial.
  • Specialized Knowledge: Expertise in Infectious Diseases, Vaccines, Covid, and Flu.
  • Core Competencies: A proven history of successful regulatory negotiations and submissions, alongside the ability to collaborate effectively across various functions.