Make your mark for patients.

We're here because we want to build the future and transform patients' lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what's possible?

We are seeking a motivated Regulatory Scientist to be an integral member of our Global Regulatory Affairs group. This person will be responsible for preparing and delivering regulatory operational plans for allocated projects/products; project managing quality regulatory submissions to agreed project targets; providing strategic and operational regulatory input and guidance in cross-functional teams; and working flexibly within and across regions providing broad operational support to ensure the delivery of product team and business objectives. This person could either be based in Raleigh, NC or Atlanta, GA.

You will contribute by:

• Supporting GRL to lead 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 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.
• Proactively liaising with the functions and participating as a member of cross-functional delivery teams for complex submissions, providing regulatory advice.
• Identifying potential regulatory risks to the operational plan and proposing 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 the development of regulatory standards and SOPs.
• Providing input into Regulatory Strategy Plans and projecting budget as delegated by GRL.
• Assisting in due diligence activities for in-licensing opportunities.

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

Minimum Qualifications:

• Bachelor's Degree
• 5+ years pharmaceutical experience with knowledge of America's regional regulatory procedures and legislation.

Preferred Qualifications:

• Flexibility and adaptability: Decide what to do based on the situation. Instinctively change behavior or approach to fit the situation or the person. Work effectively in ambiguous situations.
• Communication skills: Know when and how to communicate, using strong interpersonal and written communication skills when appropriate.
• Results focused, possessing the ability to overcome obstacles and achieve key outcomes.
• Analytical skills: Logically break situations or issues down into their essential elements, carrying out diagnosis and developing solutions.
• Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
• Organizational skills: Possess a high level of attention to detail.
• Integrity: Have an overriding commitment to integrity and high standards in self and others.
• Builder of effective partnerships: Identify opportunities and take actions to build effective relationships within team as well as externally.

#RAND

About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: "How will this create value for people living with severe disease?". We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

Curious to know more? Please visit our website .

Where permitted, applicants for employment in the United States must have received or be willing to receive a full COVID-19 vaccination by the date of hire; or, alternatively, agree to be subject to weekly COVID-19 testing, subject to religious and medical exemptions and in accordance with applicable law.

UCB is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protect by law.