​Senior CMC Regulatory Technical Writer

Location Paris
Discipline: Medical Affairs
Job type: Contract
Contact name: Jolie Trahar

Contact email: jolie.trahar@rbwconsulting.com
Contact phone: 01293364082
Job ref: JMTSCMCRTW
Published: 23 days ago
Expiry date: 19 Dec 2024 23:59

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!