Lead, Regulatory Policy and Intelligence:
UCB

53161-en_US
UCB
Smyrna Georgia
Pharmaceutical
Description

We all share one big ambition. What’s yours?

 

Everyone who works at UCB holds the same ambition – to transform the lives of people living with severe diseases.  Of course we have other associated ambitions too - including a desire to support each other in attaining all of our own personal and professional goals. That’s why we ensure every UCB colleague has the tools and environment to engage effectively in the work we do. Wherever in the world we’re based, and whatever role we play, we believe each of us can have an impact across our organization.

 

 

To help us meet our ambitions and provide the best solutions to patients, UCB is currently seeking a talented individual as serve as Lead, Regulatory Policy & Intelligence. 

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

 

EXPERIENCE/TECHNICAL REQUIREMENTS:

 

  • Must have extensive Regulatory Experience (a minimum of 10 years)
  • Proven Experience with engagement and relationship building with Regional/Local Health Authorities
  • Proven track record of strategic agility
  • Excellent communication and influencing skills
  • Education: Life Sciences to degree of Master’s
Basic Qualifications
Requirement