Senior Regulatory Writer
4 days ago
This role is responsible for preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets. The ideal candidate will have a strong background in CMC regulatory science, technical writing skills, and experience in managing multiple projects.
About the Role:
The Senior Regulatory Writer will be instrumental in preparing and submitting regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications. This includes writing CMC sections of regulatory submissions, developing and maintaining CMC regulatory dossier templates, and ensuring accuracy, consistency, and completeness of data and narratives in regulatory documents. Additionally, the candidate will oversee timelines and deliverables for multiple projects, communicate potential delays promptly, and provide guidance and training to team members as needed.
About You:
We are looking for an experienced Senior Regulatory Writer with a degree in Pharmacy, Chemistry, Biology, or a related field. A minimum of 10 years of experience in a CMC role within the pharmaceutical industry, including at least 5 years in CMC regulatory submission technical writing, is required. In-depth knowledge of CMC-related regulatory requirements and guidelines is essential. Exceptional technical writing skills, strong organizational and project management skills, proficiency in MS Office applications, and regulatory information management software are also necessary. Business level proficiency in written and spoken English is required. $120,000 - $180,000 per annum.
Location:
This position is based in Paris, France, but remote work within the UK/EU is also considered for a very experienced applicant.
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