RBW Consulting LLP seeks a Senior Regulatory CMC Project Lead to own the regulatory strategy for a late-stage small molecule asset as it approaches MAA. You will drive global CMC plans, coordinate with internal stakeholders and manage agency interactions to ensure successful submission and lifecycle management.
The role demands 10+ years in Regulatory Affairs CMC, with strong familiarity with FDA/EMA/ICH frameworks and an ability to navigate cross-functional teams across geographies.
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Remote Senior Regulatory CMC Lead, Late-Stage Small Molecule employer: RBW Consulting LLP
Join a supportive and growing GMP healthcare manufacturing facility in Trefriw, North Wales, where you will play a pivotal role in overseeing quality assurance and control activities. With a strong emphasis on career development, competitive salary, and a commitment to fostering a robust quality culture, this company offers an excellent environment for experienced professionals looking to make a meaningful impact in their field.
