Regulatory Affairs CMC Consultant

We are looking for an experienced CMC Quality Expert to support clients across all stages of drug development, from pre-clinical through to commercialisation. The role covers a wide range of modalities including small molecules, biologics, oligonucleotides, and advanced drug products.

Key Responsibilities

• Provide CMC quality and regulatory guidance across global development programs
• Author and review CMC sections for regulatory submissions ( IND/ IMPD, NDA/ BLA/ MAA)
• Perform gap analyses and define mitigation strategies for CMC pac...
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