- AbbVie (Irvine, CA)
- …+ Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries. + Provide ... supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial… more
- Genentech (South San Francisco, CA)
- …drug product, analytical development & quality control, device and delivery, regulatory CMC , manufacturing sciences, and clinical and commercial manufacturing ... and regulatory expectations. Additionally, you will oversee portfolio execution, CMC project management, and a team of technical development leaders ( CMC… more
- Lilly (Indianapolis, IN)
- …highly desirable. + Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus. + Strong leadership ... in a collaborative and fast-paced work environment. + Lead and oversee CMC process development activities for novel payloads and drug-linkers within ADC programs,… more
- Sanofi Group (Cambridge, MA)
- …in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation ... **Job Title:** Regulatory Strategist **Location** : Cambridge MA/ Morristown, NJ...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more
- Parexel (Des Moines, IA)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- Lilly (Indianapolis, IN)
- …to be used in regulatory filings. Possess ability to address key CMC regulatory questions that enable clinical studies. + Engage the external ... with other Lilly chemists, analytical chemists, bioconjugation scientists, engineers, CMC project management, Lilly manufacturing partners, and regulatory … more
- ThermoFisher Scientific (San Diego, CA)
- …and batch records + Collaborates with multiple functional lines (Pre-clinical, Clinical, CMC , Regulatory , Quality Assurance, Commercial) within the company + ... necessary to develop and manufacture API + Familiarity with regulatory and quality aspects of CMC and API activities and documentation + Ability to think… more
- Merck (West Point, PA)
- …and influences process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC ... transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group… more
- Takeda Pharmaceuticals (Boston, MA)
- …reports + investigation reports and technical reports supporting submissions + Provide regulatory CMC support by authoring/reviewing drug substance (and relevant ... development and clinical supply processes. + Demonstrated experience authoring CMC sections for regulatory submissions (eg, IND/IMPD/NDA/MAA). +… more
- Amgen (Thousand Oaks, CA)
- …+ Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing **What we ... and the drug development process + Exposure to cGMP manufacturing and CMC components of regulatory submissions **What you can expect from us** As we work to… more