Chemistry, Manufacturing & Controls Regulatory Affairs (CMC)

• Prepare, assemble and review CMC sections of human and veterinary investigational and marketing applications filed to global regulatory authorities for:
  • Parenterals, including pre-filled syringes
  • Solid dosage forms
  • Liquids, suspensions and creams
  • Modified release dosage forms
• Prepare, assemble and review sterilization validation documentation for sterile products
• Prepare, assemble and review Drug Master Files
• Prepare stability protocols and stability tables for active pharmaceutical ingredients and drug products
• Write analytical methods and validation reports
• Respond to CMC-related submission queries from US and international health authorities
• Contract and monitor analytical methods development studies

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