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Let's push the boundaries together and make the most of your talents!

Regulatory Policy & Intel Lead US

Location: 

Washington, District of Columbia, United States

Job Function:  Regulatory Affairs
Job ID:  71988

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

 

 

 

 

As part of the US Regulatory Affairs team, and in collaboration with Global Regulatory Affairs, the US Regulatory Intelligence and Policy Director will be responsible for identifying, gathering, and analyzing a broad range of regulatory intelligence, policy and legislation issues that may be of importance to UCB. The US Regulatory Intelligence and Policy Director will report to the Head of US Regulatory Affairs. This role can be based in DC, Atlanta, or Raleigh, NC.

 

You like to work in an environment where you can: 
•    Establish and maintain strong interfaces with Health Authorities; in particular, the FDA
•    Drive and shape UCB policy and shape the environment to drive patient value in the US/Americas region 
•    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

 

You will contribute by:

•    Demonstrating deep functional knowledge and stays current in the field.
•    Integrating functional expertise with business knowledge to solve problems and make good decisions for the overall business.
•    Proactively sharing expertise with other areas of the company to impact their business issues.
•    Building a work environment that promotes innovation and risk taking.
•    Motivating teams to challenge the status quo and look for opportunities to innovate.
•    Planning and executing changes with agility.
•    Generating new ideas and diverse approaches.
•    Taking action to improve processes and critiquing processes and metrics for current performance and for scaling the business.
•    Taking a long-term view and making plans for acquiring the skills and expertise needed to support the business today and, in the future.
•    Displaying a thorough understanding of drug development process and global regulatory requirements and processes.
•    Having a track record of leadership, both personal and professional.
o    Will include all UCB shared competencies, but particularly focus on working together; gathering & interpreting information; championing change; delivering impactful results, and thinking holistically

 

Interested? For this position, you’ll need the following education, experience and skills
 

Minimum Qualifications:
•    10+ years of extensive Regulatory experience
•     8+ years of experience of engagement and relationship building with Regional/Local Health Authorities

 

Preferred Qualifications:

•    Proven track record of strategic agility
•    Excellent communication and influencing skills
•    Advanced degree (MD, PharmD, Master’s) preferred

 

Why you should apply:


Do you want to contribute in bringing real value to patients living with severe diseases while driving innovation forward?

 
Join UCB’s dynamic, inspiring and innovative environment. You will be recognized for impactful performance via a competitive compensation and benefits package and you will enjoy ample personal development opportunities.


Tell us what makes you the perfect match to our team and join one of the most dynamic & forward-looking organizations in the world. 


To apply, please go to www.ucb.com/careers.  

 

 

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.


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