Global Regulatory Lead, Neurology (Raleigh, NC)

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

What youll do
Serve as the Regulatory point of contact on assigned projects providing senior management and/or attending other internal meetings with agreed-upon global regulatory strategic recommendations aligned timelines and risk/mitigation assessments for key projects.
Ensures the Global Regulatory position and strategy are agreed upon and aligned functionally (i.e. within Global Regulatory Affairs and the Regulatory Stakeholder Leadership Team) and on the respective project teams given relevant governance meetings where agreed-upon 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 youll need the following education experience and skills:
Minimum qualifications:
Bachelors degree.
Minimum of 10 years of regulatory affairs experience in the pharmaceutical industry.
Minimum of 3 years experience of global regulatory procedures and legislation for overall drug development regional regulatory experience clinical trial submission product registration line extension and license maintenance.
Minimum of 3 years experience in the area of digital and AI technologies that enhance overall drug development and regulatory strategies.
Preferred qualifications:
Masters degree.
Knowledge of neurology therapeutic area.
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.
Thorough understanding of drug development process and global regulatory requirements and processes
Up to date knowledge of the global regulatory environment good understanding of the complex set of regulations within which the organization operates and awareness of the subtleties of regulations worldwide

This positions reasonably anticipated salary range is $184000k-310800k per year. The actual salary offered will take into account internal equity and also may vary depending on the candidates 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 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 8500 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent 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 thats 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 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 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.