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We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team, based in our Raleigh, NC, or Atlanta, GA offices.
About the role
Define the strategy, planning and preparation (writing and review) of CMC submission documentation for regulatory submissions (new marketing applications, variations) from a global/regional perspective to achieve timely approvals to meet business needs.
Who you'll work with
You will work within the Regulatory CMC team and partner with other technical and regulatory functions across the business.
What you'll do
Responsible for regional and global CMC submissions in line with agreed global regulatory strategy, and within agreed timelines.
Contribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regions
Ensures effective communication of CMC regulatory strategy, risks, and overall plan to GRA Teams, Technical, Development and Commercial Teams
Highlights anticipated and ongoing critical issues arising through the product life cycle in a timely manner to senior management to enable communication to key stakeholders
Lead or contribute to ongoing process improvement and department initiatives within the CMC Regulatory Affairs function, including process improvements, SOP review and development, and evaluation/implementation of digital strategies and tools.
Interested? For this position you'll need the following education, experience and skills:
Bachelor's degree, Master's preferred in a relevant life science or business-related discipline
Demonstrated ability to leverage digital tools, structured data, and regulatory information systems to enhance CMC and Device regulatory strategy, submission quality, lifecycle management, and decision-making across global markets
Significant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC with focus on biological entities
Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological entities
Knowledge of GMP requirements, standard systems (e.g. change management systems and tools)
Effective interpersonal, presentation and communication skills with established internal and external stakeholders
Proven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills.
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.
Unless explicitly stated in the description, this role is hybrid with 40% of your time spent in the office, regardless of your current contractual agreement. If your current working arrangements differ, please contact your Talent Partner to discuss before submitting your application.
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: 93424
Recruiter: Kevin Ross
Hiring Manager: Wanja Muthoga
Talent Partner: Bianca Hinshaw
Job Level: MM II
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