Senior CMC Regulatory Technical Writer

1 month ago

London, United Kingdom CV-Library Full time

Senior CMC Regulatory Technical Writer

Are you a detail-oriented technical writer with a passion for regulatory science? Join a dynamic CMC Regulatory Department as a Senior CMC Regulatory Technical Writer. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.

Key Responsibilities:

* Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.

* Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.

* Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.

* Develop and maintain CMC regulatory dossier templates, ensuring compliance with evolving guidelines.

* Manage CMC regulatory submission workflows within the document management system.

* Ensure accuracy, consistency, and completeness of data and narratives in regulatory documents.

* Oversee timelines and deliverables for multiple projects, communicating potential delays promptly.

* Provide guidance and training to team members as needed.

Qualifications:

* Degree in Pharmacy, Chemistry, Biology, or a related field.

* Around 10 years in a CMC role within the pharmaceutical industry, including at least 5 years in CMC regulatory submission technical writing.

* In-depth knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.

* Exceptional technical writing skills with the ability to clearly communicate complex scientific information.

* Meticulous attention to detail and accuracy.

* Strong organizational and project management skills to handle multiple tasks simultaneously.

* Proficiency in MS Office applications and regulatory information management software (e.g., eCTD, Veeva).

* Business level proficient in written and spoken English.

Location:

* Hybrid from an R&D Centre in Paris, France. Remote work within the UK/ EU is also considered for a very experienced applicant.

This position will allow you to contribute to the development of groundbreaking therapies by ensuring the highest quality in regulatory submissions. Apply today to be part of a team that values excellence and innovation

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