Responsibilities

• 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 Integral 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.

Qualifications

Technical skills: <...