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CMC Dossier Writer
2 months ago
We are seeking an experienced CMC Dossier Writer to join our team at SRG, a leading recruitment company specializing in the science, engineering, and pharmaceutical sectors.
Job Summary:
The successful candidate will have a strong background in analytical chemistry and experience working with Module 3 Dossiers. They will be responsible for supporting the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers, as well as actively participating in Module 3 strategy and planning meetings.
Key Responsibilities:
- Support the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers.
- Actively participate in Module 3 strategy and planning meetings, risk assessments, and stakeholder interactions.
- Write and review regulatory submission documents and prepare responses to questions raised by Healthcare Authorities.
- Support CMC changes in response to Regulatory Intelligence.
- Support CMC aspects of Change Control for existing Licenses.
Requirements:
- Degree or equivalent in a life science subject.
- Previous experience working with Module 3 Dossiers.
- Solid understanding of analytical chemistry.
About SRG:
SRG is a UK-based recruitment company specializing in the science, engineering, and pharmaceutical sectors. We are committed to providing outstanding temporary, contract, and permanent career opportunities for our candidates and expert strategic recruitment services for our clients.
