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Regulatory Intelligence Lead for Global Clinical Development

1 month ago

Armonk, New York, United States Regeneron Pharmaceuticals Full time

Job Overview

We are seeking a skilled Regulatory Intelligence Lead to join our Global Clinical Development team at Regeneron Pharmaceuticals.

About the Role

This position will lead complex and proactive global monitoring and surveillance of changes in the regulatory landscape, focused on drug development lifecycle from preclinical through commercialization.

The successful candidate will serve as a lead contact for cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization's GxP framework.

Daily Responsibilities

  • Project management and leadership in delivering regulatory intelligence research services and information
  • Collaborating with senior leaders to develop and refine regulatory intelligence processes and procedures
  • Managing complex intelligence query requests from internal stakeholders
  • Serving as functional lead on cross-functional organizational level projects or initiatives supporting GxP compliance or requirements

Key Requirements

  • Monitoring and analyzing the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and industry thought leaders
  • Monitoring and analyzing global regulatory intelligence sources for current changes and information in the drug development space
  • Assessing regulatory intelligence information for relevance and impact on company processes, drug development projects, and/or regulatory strategies
  • Identifying business-critical aspects and communicating effectively to internal stakeholders
  • Supporting project teams, functions, and departments through regulatory intelligence collection and distribution

Qualifications

  • Advanced life science degree or related field
  • Minimum 6+ years experience in biotech/pharmaceutical industry with strong focus in Regulatory Intelligence
  • Good understanding of drug development and commercialization process, focusing on clinical development and trial execution
  • Experienced in understanding and interpreting regulatory guidelines and documents
  • Ability to research, analyze, and extrapolate critical regulatory information, focusing on clinical requirements and recommendations

Salary Range

$129,800.00 - $211,800.00 annually, depending on qualifications and experience