Related skills
regulatory affairs ich guidelines quality control cmc regulatory writing📋 Description
- Authoring regulatory submissions: drafting/reg reviewing CMC for NDAs/MAAs.
- Ensuring compliance with regulatory bodies and ICH guidelines.
- Collaborating with SMEs across science, QA, and manufacturing.
- Maintaining high-quality, concise, scientifically accurate documents.
- Managing timelines to meet submission schedules.
- Identifying and communicating potential CMC regulatory issues.
🎯 Requirements
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field.
- 5–9 years in Regulatory Affairs with deliverable ownership.
- Experience authoring CMC sections for regulatory submissions.
- Technical writing, editing, and clear scientific communication.
- Strong regulatory knowledge across APAC, US, and EU; eCTD experience.
- Industry familiarity with pharmaceutical manufacturing/quality control.
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