Global Regulatory CMC Scientist (Atlanta)
Hybrid · Atlanta, Georgia, United States or Raleigh, North Carolina, United States
Job Summary
Define the strategy, planning, and preparation (writing and review) of CMC submission documentation for regulatory submissions from a global/regional perspective to achieve timely approvals. Work within the Regulatory CMC team and partner with other technical and regulatory functions. Responsible for regional and global CMC submissions in line with global regulatory strategy and timelines. Contribute to HA interactions on CMC matters in all regions, communicate CMC strategy and risks to GRA Teams and Development/Commercial Teams, and highlight critical issues to senior management. Lead or contribute to process improvements and SOP reviews within the CMC Regulatory Affairs function, including digital strategies and tools. Education and experience required include a Bachelor’s degree (Master’s preferred) in life sciences or business, extensive Regulatory Affairs CMC experience with focus on biological entities, GMP knowledge, and strong communication and leadership capabilities.
Required Qualifications
- Bachelor’s degree in life sciences or a related field; Master’s degree preferred
- Significant experience in pharmaceutical Regulatory Affairs CMC, with focus on biological entities
- Proven track record delivering CMC sections of marketing authorisations for new biological entities
- Knowledge of GMP requirements and standard systems (change management tools)
- Experience authoring and contributing to CMC documentation for regulatory submissions
- Ability to leverage digital tools, structured data, and regulatory information systems to enhance regulatory strategy and submission quality
- Strong interpersonal, presentation, and communication skills with internal and external stakeholders
- Proven leadership, problem-solving, flexibility, influence, and teamwork skills
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