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28 Oct 2020

Full-Time Regulatory Science Lead

UCB Bioscience – Posted by UCBdenise Raleigh, North Carolina, United States

Job Description

To strengthen our Regulatory Affairs Team, we are looking for a talented individual to fill the position of Regulatory Science Lead. This position can be based in Atlanta, GA or Raleigh, NC.

 

You like to work in an environment where you can:
•    Prepare and deliver regulatory operational plans for assigned projects/products within a specific region.
•    Provide strategic and operational regulatory input and guidance in cross-functional teams.
•    Manage quality regulatory submissions to agreed project targets.
•    Work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.

 

You will contribute by:
•    Supporting the Global Regulatory Leader (GRL) for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and regional/local country regulations.
•    Leading the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
•    Liaising proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
•    Identifying potential regulatory risks to the operational plan, and propose options to mitigate risks.
•    Providing regulatory expertise on regulatory submissions, health authority briefing documents and response documents
•    Assuming assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL.
•    Maintaining awareness of competitors’ activities and share potential impact these activities may have on the product development program
•    Delivering project assignments supporting the business e.g. representation on functional workstreams
•    Ensuring that appropriate, up-to-date records are maintained for compliance
•    Assisting in development of regulatory standards and SOPs
•    Providing input into Regulatory Strategy Plans and project budget as delegated by GRL
•    Assisting in due diligence activities for in-licensing opportunities

 

Minimum Qualifications:
•    Bachelor’s degree required
•    5+ years pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation

 

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.

How to Apply

https://careers.ucb.com/job/Raleigh-Regulatory-Science-Lead-Nort/628969501/?locale=en_US

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: Not Disclosed.

Job expires in 56 days.

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