Global Regulatory CMC Scientist (Raleigh)
Hybrid · Raleigh, North Carolina, United States or Brussels, Brussels Capital, Belgium
Job Summary
Lead the global/regional strategy, planning, and preparation of CMC submission documentation (new marketing applications, variations) from global/regional perspectives to enable timely regulatory approvals. Contribute to HA interactions on CMC matters across regions, ensure timely submissions and effective communication of regulatory strategy and risks to cross-functional teams, and drive process improvements within the CMC Regulatory Affairs function. Requires experience authoring CMC sections for biological entities, familiarity with GMP, and strong collaboration across regulatory, technical, development, and commercial teams. Hybrid work model with offices in Raleigh (US) and hubs in Brussels (BE) and Slough (GB).
Required Qualifications
- Bachelor’s degree in life sciences or related field
- Master’s degree preferred in life sciences or business-related discipline
- Significant experience in Regulatory Affairs CMC with focus on biological entities
- Proven authoring/contribution to CMC sections for new biological entities
- Knowledge of GMP requirements and standard systems
- Strong interpersonal, presentation, and communication skills
- Proven leadership and teamwork abilities
Desired Qualifications
- Bachelor’s degree
- Master’s preferred
- Significant experience in pharmaceutical industry in Regulatory Affairs CMC with focus on biological entities
- Proven track record of authoring and delivering CMC sections of marketing authorisations for new biological entities
- Knowledge of GMP
- Effective interpersonal, presentation and communication skills
- Leadership, problem-solving, flexibility, influence, and teamwork skills
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