- Parexel (Raleigh, NC)
- …and approved programs, helping to shape the future of life-saving therapies. As a **CMC Regulatory Affairs Senior Associate ** , you will play a ... (advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry. + Proven experience… more
- Sumitomo Pharma (Raleigh, NC)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- United Therapeutics (Raleigh, NC)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...Ability to mentor, coach, guide, and train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of… more
- Amgen (Holly Springs, NC)
- …Quality, Engineering, Process Development, Analytical Sciences, Supply Chain, and Regulatory Affairs . + Influence site-wide decision-making on deviation ... to site and global leadership. + Present investigations and findings to regulatory inspectors, internal auditors, and senior leadership. + Partner… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... ** Associate Director, Small Molecule Analytical Development** + Lead...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
- United Therapeutics (Research Triangle Park, NC)
- …across multiple functional groups (eg, Research and Development, Manufacturing, Validation, Regulatory Affairs , etc.). Negotiate and manage expectations across ... expertise and mentoring or developing a member of your team. The Associate Director, QA Engineering will provide advanced support and subject matter technical… more