Global Regulatory CMC Scientist (Atlanta)

Make your mark for patients We are looking for a Regulatory CMC Scientist to join 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. Ensure effective communication of CMC regulatory strategy, risks, and overall plan to GRA Teams, Technical, Development and Commercial Teams. Highlight 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. Requirements 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. 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! 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 View email address on click.appcast.io 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. #J-18808-Ljbffr UCB