- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical ... Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical… more
- West Pharmaceutical Services (Exton, PA)
- …a healthier environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist , Regulatory Project Management (RPM) role is ... Sr. Specialist , Regulatory Project Management (Evergreen Posting)...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Novo Nordisk (Lexington, MA)
- …Are you ready to make a difference The Position The Clinical Pharmacology Specialist can be accountable for the Clinical pharmacology strategy for phase 1-4 in ... is highly cross-functional and may involve some travel. Relationships Reports to the Senior Director, Clinical Pharmacology for the US East Coast Hub. Will interact… more
- Astellas Pharma (Sanford, NC)
- …For more information, please visit our website: www.astellasgenetherapies.com. **The Role:** The Senior Specialist , QC Systems Support will be responsible for ... external audits; Assists in the preparation and review of CMC regulatory submissions + Collect and report,...and training to junior colleagues **Quantitative Dimensions:** The QC Specialist IV, QC Systems Support will be responsible for… more
- Verista (Boston, MA)
- …in a pharmaceutical setting: + Cell and gene therapy cGMP's and associated CMC regulatory considerations + Aseptic processing + Experience successfully leading ... event investigations, Root Cause Analysis and CAPA + Experience with network-based applications such as Oracle, TrackWise + Master's degree with 2-3 years of relevant work experience, or Bachelor's degree in a scientific or allied health field with minimum 3-5… more
- ThermoFisher Scientific (New Brunswick, NJ)
- …company, all while maintaining full-time benefits. **Key responsibilities:** As a Senior Scientist, you will be part of the Analytical Regulated Testing ... Participates in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.... inspections. + Effective teamwork and communication with the CMC sub teams to ensure all API and drug… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... overlay in a timely manner. * Review clinical trial protocols and related regulatory documents to prepare a billing plan for all medical procedures and services… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include: Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... budget overlay in a timely manner. * Review clinical trial protocols and related regulatory documents in order to prepare a billing plan for all medical procedures… more