Regulatory Scientist

Make your mark for patients

We are looking for a Regulatory Scientist who is motivated, ambitious and eager to learn to join us in our Global Regulatory Affairs team, based in our Atlanta, GA or our Raleigh, NC offices.

About the role:

You 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.

Who you'll work with:

The Regulatory Scientist reports to the Regulatory Science Lead for the asset. You will work with the Regulatory Science Lead, the GRL, other members of the Regulatory Team and cross-functional team members.

What you'll do:

• Support the GRL and Regulatory Science Lead 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.
• Lead 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 liaise with the functions and participating as a member of cross-functional delivery teams for complex submissions, providing regulatory advice.
• Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents.
• Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL and Regulatory Science Lead.
• Maintain awareness of competitors' activities and share potential impact these activities may have on the product development program.
• Deliver project assignments supporting the business (e.g., representation on functional workstreams.)

Interested? For this role, we're looking for the following education, experience, and skills:

• Bachelor's Degree plus 5+ years pharmaceutical experience with knowledge of America's regional regulatory procedures and legislation.
• 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.
• Organizational skills: Possess a high level of attention to detail.
• Integrity: Have an overriding commitment to integrity and high standards in self and others.

This positions reasonably anticipated base salary range is $121,90,000 - $160,000 per year. The actual salary offered will take into account internal equity and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience, among other factors.

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

RANDATUCB

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.