Global Regulatory Lead (Atlanta, GA) Position Available In Fulton, Georgia

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 Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months.

Please inform your Manager or your Talent Partner before applying to any internal job opportunities. 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.

Requisition ID:

90531

Recruiter:

Kelly Dickinson Hiring Manager:

Tom Meeusen Talent Partner:

Bianca Hinshaw Job Level:

SM II – SM I

Please consult HRAnswers for more information on job levels.