Head of US Regulatory Affairs

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Date: Jul 16, 2019

Location: Atlanta, Georgia, US

Head of US Regulatory Affairs

UCB Biosciences

Atlanta, GA

Job Summary

The Head of US Regulatory Affairs provides regulatory oversight for therapeutic/disease area(s), senior leadership and mentorship for PVU deployed Global Regulatory Leads (GRLs) and line manages Practice based GRLs, regulatory science staff, labeling, advertising and promotion staff and regulatory intelligence and policy staff within the US. The Head of US Regulatory Affairs will work with Patient Value Unit (PVU) leadership to provide therapeutic area regulatory strategies and disease state insights; regulatory vision and direction to add patient value and product differentiation; recommendations to optimize the portfolio; and leadership to establish an external network to keep abreast of trends affecting the franchise. The Head of US Regulatory Affairs will collaborate with all UCB regions on global regulatory strategies within therapeutic/disease areas of responsibility.

 

Major Accountabilities

  • Recruit, develop, and retain highly talented and skilled regulatory scientists, labeling, advertising and promotion staff and regulatory intelligence and policy staff
  • Responsible for providing regulatory leadership specific to the US therapeutic/disease area strategies to PVU leadership.
  • Ensures regulatory resources are provided for early and late stage development and life cycle projects (in conjunction with the GRL).
  • Ensure that regulatory therapeutic/disease area strategic options, assessments, and risks specific to the US are communicated to the PVU. 
  • Accountable for achieving US regulatory alignment for disease area regulatory strategy with input from PVU leadership, GRLs, and Regional Leads.
  • Liaise with Global Business Development regarding TA Due Diligence assignments and provide input to due diligence projects as required.
  • Awareness & application of global regulatory environment within the US region (e.g. Health Authority guidance, new approvals, overall regulatory landscape).
  • Drives a culture of excellence and motivates employees to perform at their highest ability.
  • Provide high level strategic US regulatory direction and mentorship to GRLs including general regulatory strategies, regulatory strategic development plans and risk assessments, regulatory critical issue management.
  • Lead special regulatory projects/process initiatives of high complexity, ensuring global alignment.
  • Act as interface between PVU and US PVO Leadership teams and GRA and build partnerships with PVU leadership and other PV Practices and Regions to ensure that strategic business goals are met through the sharing of knowledge and the provision of appropriate resources.
  • Proactively manage critical issues, taking leadership for the regulatory contribution. Within the US region, influences policies, guidance development and represents the company at key external meetings.
  • Accountable for ensuring GRA provides appropriate Regulatory support in terms of talent, strategy, tactical and operational support for the US.
  • Has dotted-line reporting with PVU deployed GRLs to ensure GRL development support, right talent in right place at right time and for ensuring very strong regulatory leadership and innovative and strategic thinking is applied
  • Accountable for developing top talent within the GRA Community (direct reports and GRLs) by providing stretch goals, coaching and mentoring for success
  • Accountable for providing resources necessary to achieve PVU goals and objectives
  • Responsible for developing credible and trustful relationships internally and externally, with specific emphasis on the FDA.

Education and Qualification

  • A minimum of 15 years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 15 years regulatory and/or related experience. 
  • US regulatory experience (Americas, EMEA; APAC a plus) required with a proven track record of significant regulatory accomplishments
  • Thorough understanding of drug development process and global regulatory requirements and processes
  • Up to date knowledge of the US regulatory environment; thorough understanding of the complex set of regulations within which the organization operates and awareness of the subtleties of regulations worldwide.
  • Up to date knowledge and appreciation of the science driving drug discovery & development processes and product lifecycles.
  • Demonstrated ability to make compelling scientific and/or strategic arguments to support all regulatory aspects related to the therapeutic/disease area.
  • Ability to read, interpret, evaluate and disseminate regulatory guidance and policy to ensure regulatory compliance, including ability to analyze impact on UCB strategic direction and operations.
  • Financial Management
  • Proactive maintenance of budget by prioritization and good decision making.
  • Track record of leadership, both personal and professional

Competencies

Demonstrated excellence in the core competency areas of process management, decision-making, leading innovation and change, strategic agility, driving for results, applying technical expertise, business knowledge, communication, collaboration and teamwork, developing yourself and others as well as building and leading teams. 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 staff and others to challenge the status quo and look for opportunities to innovate
  • Has a 2 or more year planning horizon to ensure the needs of the business are met
  • Plans and executes changes with agility
  • Takes action to improve processes and critiques processes and metrics for current performance and for scaling the business
  • Generates new ideas and diverse approaches
  • Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals
  • Takes a tough stand on inappropriate behavior
  • Takes a long term view and makes plans for acquiring the skills and expertise needed to support the business today and in the future
  • Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Strong in working well with others, within teams and working with senior leadership
  • Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way.


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