to work in our office three days per week on average. Position Summary The Associate Director, Regulatory CMC..., is responsible for contributing to/assisting with the development and implementation of global regulatory CMC strategies supporting...
: Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the..., but are not limited to): Responsible for the regulatory CMC leadership of one or more commercial and development projects, including...
effectively with multidisciplinary teams including clinical, regulatory, nonclinical, and CMC functions to ensure alignment... model requires this role to work in our office three days per week on average. Position Summary The Director of Clinical...
manufacturing partners. The Senior Director will define long-term drug substance strategy, support CMC development and commercial... and Quality Assurance in assessing their impact on regulatory filings. Initiate and coordinate the preparation of CMC...
Development Plan (gPDP) covering clinical, nonclinical, CMC, regulatory, and commercial considerations. Partners proactively... Program Team Leader (Sr. Director) is responsible for program strategy and achievement of development milestones from pre-IND...
(FDA, EMA, ICH, USP). Partners cross-functionally with Quality Assurance, Manufacturing, Regulatory Affairs, and CMC teams... scientific leadership, oversees method lifecycle management, and ensures QC systems meet all applicable regulatory requirements...
from pre-formulation, formulation development, synthetic process development, manufacturing, regulatory CMC and quality... of formulation development for drug products with various dosage forms Strong knowledge of cGMPs, including CMC regulatory...
: Support activities related to Clinical Trial Material (Phase 1-4); providing support to the Director, Clinical Supplies.... This position will interface with Clinical, Project Management, Regulatory, QA, Manufacturing and teams. The Senior Specialist...
Medicine, Biostatistics, Clinical Operations, Regulatory Affairs, and CMC to ensure seamless program execution, recognizing the... medicine. The exact title (Medical Director, VP, SVP) will be determined based on the candidate's experience, scope...