Location
Monheim (Landkreis Donau Ries), Landkreis Donau Ries | Germany
Job description
Make your mark for patients
We are looking for a Global Regulatory Affairs Lead who is Strategic, collaborative, and dynamic to join us in our Global Regulatory Affairs team, based in our sites either in UK, Germany, Belgium, or US.
About the role
You will play a pivotal role in leading and providing regulatory leadership to an assigned mission, leading the Regulatory Strategy team (RST) for assigned projects and ensuring the Global Regulatory strategy is executed regionally. You will act at the primary point of contact within UCB for any regulatory queries and interactions with health authorities and lead Mission Regulatory discussions internally as part of the Patient Value Unit.
Who you’ll work with
You will work with a number of key internal regional and global stakeholders as well as act as the main point of contact for the mission to the Health authorities.
What you’ll do
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-Lead as the Regulatory point of contact on the assigned Mission with senior management, providing the agreed global regulatory strategic recommendations and risk assessment for key projects.
-Join and participate as a Global Regulatory representative on other relevant governance teams representing the agreed global regulatory functional view.
-Be accountable for the timely development and implementation of the global regulatory strategy and plan(s) designed to meet the needs of the business and patients for assigned Missions and/or
projects ultimately leading to approval with a viable label.
-Manage all key deliverables including program and document submissions, risk mitigations, product negotiations and global health authority interactions ensuring global alignment.
-Participate and contribute to the Patient Value Unit global strategic initiatives and tactical plans related to the gathering and analyses of customer insights in the field and the consequential design/adaptation of Mission/PST business strategies.
-Contribute to Chairing the global Regulatory Strategic Team meeting for the Mission and/or product, to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
-Lead and coordinate, on behalf of the Mission/PST, discussions around Practice resource needs and Mission regulatory budget in order to deliver Mission/PST and agreed upon GRA objectives.
-Assist in regulatory initiatives (internal or external) leading to process improvement and development of specialized expertise as needed.
-Contribute as the regional lead (depending on phase of project) when required.
I
nterested? For this role we’re looking for the following
education, experience
and
skills
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-Strong experience in Regulatory Affairs within a Pharmaceutical company.
-Knowledge of global regulatory procedures for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension and license maintenance.
-Ability to work in a cross- functional environment, contributing within drug development and global and local regulatory strategies.
-Proven track record of contributing to delivering regulatory approvals.
-Experience in interacting with and negotiating with health authorities.
-Experience with people management and cross-functional matrix management.
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.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities Apply on
EMEA-Reasonable_Accommodationucb. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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