Global Regulatory CMC Scientist (UK)
Hybrid · Atlanta, Georgia, United States or Raleigh, North Carolina, United States
Job Summary
Regulatory CMC Scientist to define strategy, planning and preparation (writing and review) of CMC submission documentation for regulatory submissions from a global/regional perspective to achieve timely approvals. Responsibilities include leading or contributing to regional and global CMC submissions, providing CMC input to HA interactions across regions, communicating CMC regulatory strategy and risks to GRA, Technical, Development and Commercial teams, flagging critical issues to senior management, and driving process improvements within the CMC Regulatory Affairs function. Requires significant experience in pharmaceutical Regulatory Affairs CMC with a focus on biological entities, track record of delivering CMC sections for marketing authorisations, knowledge of GMP, and strong collaboration skills. Hybrid work model with offices in Brussels, Slough, Raleigh, and Atlanta; global/regional coordination to support regulatory submissions across global markets.
Required Qualifications
- Bachelor’s degree in life sciences or related field
- Master’s degree preferred in life science or business-related discipline
- Significant experience in pharmaceutical Regulatory Affairs CMC with focus on biological entities
- Proven ability to author and contribute to CMC sections of marketing authorisations for new biological entities
- Knowledge of GMP and regulatory submission systems/tools
- Strong interpersonal, presentation and communication skills with stakeholders
- Proven leadership, problem-solving ability, flexibility, influence, and teamwork
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