UCB
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Global Regulatory Lead (Raleigh, NC)
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UCB 6 days ago Be among the first 25 applicants Join to apply for the
Global Regulatory Lead (Raleigh, NC)
role at
UCB Make your mark for patients
We are looking for a Make your mark for patients
We are looking for a
Global Regulatory Lead
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
What You’ll 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 you’ll need the following education, experience and skills:
Minimum qualifications:
Bachelor’s 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:
Master’s 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 position's reasonably anticipated salary range is $184,000k-310,800k per year. The actual salary offered will take into account internal equity and also may 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 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 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. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at UCB by 2x Sign in to set job alerts for “Regulatory Specialist” roles.
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Global Regulatory Lead (Raleigh, NC)
role at
UCB 6 days ago Be among the first 25 applicants Join to apply for the
Global Regulatory Lead (Raleigh, NC)
role at
UCB Make your mark for patients
We are looking for a Make your mark for patients
We are looking for a
Global Regulatory Lead
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
What You’ll 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 you’ll need the following education, experience and skills:
Minimum qualifications:
Bachelor’s 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:
Master’s 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 position's reasonably anticipated salary range is $184,000k-310,800k per year. The actual salary offered will take into account internal equity and also may 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 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 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. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at UCB by 2x Sign in to set job alerts for “Regulatory Specialist” roles.
REMOTE - Quality Assurance Specialist (Clinical Research)
Multilingual Medical Information Specialist
Senior PV Specialist (legal/medical review)
Regulatory - Sponsor Dedicated - CMH Experience (Home-based, US or Canada)
Morrisville, NC $95,000.00-$175,700.00 1 day ago Quality Assurance Specialist (Clinical Research)
Holly Springs, NC $36.00-$39.00 2 weeks ago Regulatory Affairs - Labeling Strategy, Senior Manager
Raleigh, NC $145,000.00-$165,000.00 4 days ago Quality Improvement Specialist (Full-time Remote, North Carolina Based)
Quality Assurance - Batch Related Documents
Raleigh, NC $120,000.00-$160,000.00 22 hours ago Morrisville, NC $70,100.00-$126,100.00 1 day ago Quality Controls : Life Sciences - Cary, North Carolina Req 27324
Senior Collateral and Quality Control Specialist
RBC Bank Regulatory Relations Associate Director
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr