- Authoring of CMC sections (Drug Product and/or Drug Substance) for new registration applications in CTD format, in alignment with global regulatory strategies and current regulatory guidelines.
- Authoring and reviewing CMC documentation to support variations and commitments resulting from interactions with Health Authorities.
- Partner with Global Regulatory Affairs (GRA) to support new registrations and worldwide post‑approval changes.
- Conduct Gap Analyses and/or Due Diligence assessments of the Quality sections of Global Dossiers.
- Ensure regulatory compliance of CMC sections for global products and drug substances throughout the product lifecycle.
- Evaluate the regulatory impact of quality-related change controls.
- Support QA in the qualification of Third Parties (CMOs).
- Prepare and/or publish eCTD sequences related to CMC content.
Job RequirementsTechnical skills
- Degree in Relevant Scientific Discipl...