Senior CMC Regulatory Technical Writer

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:

1. Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.
2. Write CMC sections of regulatory submissions, including Modules 2.3 and 3 of the CTD, and briefing documents for Health Authority consultations.
3. Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.
4. Develop and maintain CMC regulatory dossier templates, ensuring compliance with evolving guidelines.
5. Manage CMC regulatory submission workflows within the document management system.
6. Ensure accuracy, consistency, and completeness of data and narratives in regulatory documents.
7. Oversee timelines and deliverables for multiple projects, communicating potential delays promptly.
8. Provide guidance and training to team members as needed.

Qualifications:

1. Degree in Pharmacy, Chemistry, Biology, or a related field.
2. Around 10 years in a CMC role within the pharmaceutical industry, including at least 5 years in CMC regulatory submission technical writing.
3. In-depth knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.
4. Exceptional technical writing skills with the ability to clearly communicate complex scientific information.
5. Meticulous attention to detail and accuracy.
6. Strong organizational and project management skills to handle multiple tasks simultaneously.
7. Proficiency in MS Office applications and regulatory information management software (e.g., eCTD, Veeva).
8. 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.