Global Regulatory CMC Scientist (Atlanta)

UCB • Atlanta, GA

2d • Hybrid

About The Position

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. You will work within the Regulatory CMC team and partner with other technical and regulatory functions across the business.

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.

Responsibilities

• 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.

Benefits

• Hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity.
• 40% of your time spent in the office.
• Equal opportunity employer.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior