CMC

We are looking for a Technical & Regulatory Writer to support the preparation of scientific and regulatory documentation related to pharmaceutical analytical development.

The role involves translating analytical data and technical information into clear, accurate, and compliant documentation for pharmaceutical development and regulatory submissions.

Key Responsibilities

• Prepare and review technical and regulatory documents related to analytical method development and validation.
• Draft scientific reports and CMC documentation for regulatory submissions.
• Compile and summarize analytical data in collaboration with cross-functional teams.
• Ensure the accuracy, consistency, and compliance of documentation with applicable regulatory requirements.
• Coordinate document reviews with analytical development and regulatory affairs teams.

Candidate Profile

• Degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific field.
• Experience in technical or regulatory writing within the pharmaceutical industry.
• Good understanding of analytical method development and validation.
• Familiarity with CMC documentation, CTD structure, and relevant regulatory guidelines.
• Strong scientific writing and communication skills.
• Excellent command of English and strong attention to detail.