Technical Writer and Regulatory Consultant
4 weeks ago
About the Position:
RBW Consulting is seeking a seasoned Senior CMC Regulatory Technical Writer to join our team. As a key member of our regulatory department, you will play a critical role 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.
Requirements:
- 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.
Why Join Us:
At RBW Consulting, we believe in creating a positive and inclusive work environment where our employees can thrive. We offer a competitive salary of €85,000 per year, plus benefits and opportunities for professional growth and development.
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