Director, Regulatory Affairs - Chicago, IL
- Serves as Deputy to VP, Regulatory Affairs, and assumes VP
responsibilities when delegated;
- As a senior member of the Regulatory Affairs Dept and Regulatory
Oversight Committee, participates in formulation of global oversight and
- Has overall US regulatory responsibility for several therapeutic areas;
- Has individual responsibility for planning/managing/executing global
regulatory activities for area and product specific projects;
- Builds/strengthens key external (Regulatory Agency, external experts,
industry organizations, etc) contacts;
- Actively participates in one or more significant industry committees (DIA,
- Responsible for devising/maintaining process to review and interpret
regulatory agency documents to:
- Provide company feedback to regulatory agencies, and
- Provide guidance to company's development functions.
Qualifications / Requirements:
- Advanced degree required;
- 15+ years pharmaceutical drug experience;
- 13+ years direct regulatory affairs experience;
- Specific experience in rarely occurring, highly visible/highly
important regulatory interactions such as participating in/preparing the
project team for FDA Advisory Comm. meetings or EU equivalent, interaction
with FDA Ombudsman process, etc.;
- Previous experience serving on industry external committees (DIA,
PhRMA) a plus.
- Previous management experience;
- 20% travel.
- Base Salary: $130k - $170k, plus 15%-20% performance bonus and
- Full relocation assistance is provided.
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