Global Regulatory CMC Scientist
Hybrid · Atlanta, Georgia, United States or Raleigh, North Carolina, United States
Job Summary
Regulatory CMC Scientist responsible for defining 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. Lead or contribute to regional and global CMC submissions, provide regulatory CMC input to HA interactions in all regions, communicate CMC strategy and risks to GRA, Technical, Development and Commercial Teams, highlight critical issues to senior management, and drive process improvements within the CMC Regulatory Affairs function. Role requires experience authoring CMC sections for new biological entities, knowledge of GMP requirements, and strong collaboration across multidisciplinary teams. Hybrid work arrangement with 40% in-office time in Brussels, Slough, Raleigh, or Atlanta.
Required Qualifications
- Bachelor’s degree in life science or business-related discipline
- 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
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.