Regulatory CMC Technical Lead Consultant
Core
Create and maintain CMC regulatory documents for small molecule drug products to support global submissions to regulatory authorities.
Role type
Senior Regulatory CMC Technical Lead Consultant
Builds
Marketing authorization applications, investigational applications, and variations/supplements for small molecule drugs
Domain
Pharmaceutical regulatory affairs (CMC)
Required skills
CMC regulatory document authoring, CTD M2/M3 section expertise, life cycle management of quality variations, global CMC regulations knowledge (ICH, US, EU), manufacturing technical transfer, comparability regulatory requirements, quality management software proficiency
Preferred skills
Biologics experience, Antibody-Drug Conjugates (ADCs) experience
Technologies
TrackWise, regulatory document information management systems
Responsibilities
Author and review CMC sections for new and variation applications, advise multidisciplinary teams on agency requirements, review change control requests, agree on regulatory strategy for product life cycle, negotiate with regulatory agencies on CMC strategies, represent during GMP inspections, support due diligence activities
Seniority
Senior, hands-on IC