Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch
Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines
Oversee critical development activities including process development, scale-up, manufacturing validation, analytical method development, and packaging/labeling evaluation
Manage cross-functional collaboration as a Subject Matter Expert and Technical Lead, partnering with internal teams and external manufacturing partners (CDMOs/CMOs) to ensure seamless program execution
Champion quality and compliance by implementing Quality by Design principles, cGMP standards, and risk-based strategies that support clinical trials, regulatory approvals, and commercial success
Build and mentor high-performing teams while managing budgets and timelines to deliver robust, scalable, and cost-effective pharmaceutical solutions

Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
Advanced scientific and regulatory knowledge of drug, biologic, or device development
15 years’ post-degree of directly relevant experience in drug, biologic, or device development preferred

Skills:

Critical thinking and analytical skills, financial acumen, influencing and leading teams, risk assessment, problem solving skills, decision making, strong written and verbal communication skills in English
Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
Quality focus
Strong emotional intelligence, customer focused leadership and decision-making skills
Innovative, creative, and practical thinking including problem-solving skills

Benefits of working at Allucent include:

VP CMC, Senior Strategist CMC – Contractor

Key skills