Director of Regulatory

Director, Regulatory Affairs - Chicago, IL

Responsibilities:

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 management strategy;
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, PhRMA, etc);
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.

Compensation:

Base Salary: $130k - $170k, plus 15%-20% performance bonus and "all-employee" bonus;
Full relocation assistance is provided.