Global Regulatory Lead (UK)

UCB S.A.; Slough; On-site; GBP 75,000 - 110,000; Full time

Job summary

UCB S.A. is seeking a Global Regulatory Lead for Neurology to lead regulatory strategies in drug development. The role entails working closely with cross-functional teams to ensure regulatory compliance while focusing on patient needs. The ideal candidate will have a strong background in pharmaceutical regulatory affairs, ideally with a bachelor's degree and experience in managing complex regulatory processes.

Qualifications

• Several years’ experience in pharmaceutical regulatory affairs.
• Global regulatory experience is a plus.
• Experience in clinical trial submission and product registration is vital.

Responsibilities

• Serves as the Regulatory point of contact on assigned projects.
• Accountable for developing global regulatory strategy and plans.
• Ensures alignment of regulatory strategies across project teams.

Skills

Knowledge of global regulatory procedures

Cross-functional project management

Understanding of digital and AI technologies

Education

Bachelor's degree

Job description

Make your mark for patients

We are looking for a Global Regulatory Lead - Neurology to join us in our Global Regulatory Affairs team, based in any of our Brussels (Belgium), Slough (UK) or Atlanta or Raleigh (US) offices.

About the role

The Global Regulatory Affairs Leader provides regulatory leadership tailored to the assigned candidate asset or brand. The Global Regulatory Lead leads the global Regulatory Strategy Team for assigned projects and is a key member of the project team.

Who you’ll work with

The role reports into the Global Regulatory Strategy Team Lead - Neurology

What you’ll do

• Serve as the Regulatory point of contact on the assigned projects with senior management and/or at other internal meetings providing the agreed global regulatory strategic recommendations, aligned timelines and risk/mitigation assessment for key projects.
• Ensures the Global Regulatory position/strategy is agreed and aligned functionally (ie within Global Regulatory Affairs, Regulatory Stakeholder Leadership Team) and on the respective project teams in view of relevant governance meetings where agreed global regulatory functional views are presented.
• Accountable for the timely development and implementation of the global regulatory strategy and plan(s). These plans are based on an agreed Target Patient Value Profile designed to meet the needs of the business and patients for assigned projects (to deliver timely product milestones (e.g. Health Authority meetings, new indications, etc.), ultimately leading to approval with a viable label meeting the needs of patients and the business.
• Accountable for delivering all regulatory milestones related to the assigned projects including assessment of the approvability of the program submissions together with global regulatory risk mitigation measures (supported by the regions as appropriate).
• Accountable for the review of global/regional submission key documents (as applicable) and ensuring global alignment of key messages in line with Asset Team objectives.

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

• Bachelor’s degree required
• Several years’ experience in pharmaceutical regulatory affairs.
• Knowledge of global regulatory procedures and legislation for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension and license maintenance. Global regulatory experience is a plus.
• Global and integrated cross-functional view into pharmaceutical project management and drug development/approval and commercialization. Ability to appreciate multiple cross-functional elements contributing within drug development and ability to develop an adequate and coherent supportive global/local regulatory strategy.
• Knowledgeable in the area of digital and AI technologies that enhance overall drug development and regulatory strategies

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

UCB is an equal opportunity employer.All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail] 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.