Lead, Regulatory Policy and Intelligence

Job Details

Company Name

UCB Pharma

Location

Smyrna, GA

Expiration Date

Sunday, April 15, 2018

Interest Area

Communication, Consulting, Policy

Position Type

Full-Time

Position Level

Mid-career

Minimum Degree Requirements

Masters Degree

Job Posting URL

The Lead, Regulatory Policy & Intelligence role is responsible for:

 

  • Establishing networks with FDA and industry associations
  • Leading key topics of interest to UCB internally and externally as part of shaping the environment
  • Shepherding documents through internal process for guideline commenting and input
  • Communication of Regulatory Intelligence including impact analyses
  • Managing other US Regulatory Policy & Intelligence staff

 

MAJOR ACCOUNTABILITIES:

 

  • Establish and maintain strong interfaces with Health Authorities in particular FDA
  • Drive and shape UCB policy and shape the environment to drive patient value in their region (US/Americas)
  • Provide expertise into the teams to ensure FDA needs and requirements are understood and included where appropriate
  • Work in a matrix environment where connectivity is paramount and is a priority over reporting lines

 

EXPERTISE:

 

Demonstrated excellence in the core competency areas of decision-making, leading innovation and change, strategic agility, process management, driving for results, applying technical expertise, business knowledge, communication, collaboration and teamwork, and developing yourself. Specific examples of behaviors supporting these competencies include:

 

  • Demonstrates deep functional knowledge and stays current in the field
  • Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business
  • Proactively shares expertise with other areas of the company to impact their business issues
  • Builds a work environment that promotes innovation and risk taking
  • Motivates teams to challenge the status quo and look for opportunities to innovate
  • Plans and executes changes with agility
  • Generates new ideas and diverse approaches
  • Takes action to improve processes and critiques processes and metrics for current performance and for scaling the business
  • Takes a long term view and makes plans for acquiring the skills and expertise needed to support the business today and in the future
  • FDA regulatory experience required with a proven track record of significant regulatory accomplishments
  • Thorough understanding of drug development process and global regulatory requirements and processes
  • Track record of leadership, both personal and professional
  • Will include all UCB shared competencies, but particularly focus on:
    • Working together
    • Gathering & Interpreting information
    • Championing Change
    • Delivering impactful results
    • Thinking holistically