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- Tasks: Prepare and submit high-quality CMC regulatory documents for clinical and marketing applications.
- Company: Join a dynamic CMC Regulatory Department focused on innovative therapeutic assets.
- Benefits: Enjoy hybrid work options and the chance to contribute to groundbreaking therapies.
- Why this job: Be part of a team that values excellence, innovation, and impactful science.
- Qualifications: Requires a degree in Pharmacy, Chemistry, Biology, and 10 years in CMC regulatory writing.
- Other info: Remote work considered for experienced applicants; based in Paris, France.
The predicted salary is between 48000 - 72000 £ per year.
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
Senior CMC Regulatory Technical Writer employer: RBW Consulting
Contact Detail:
RBW Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior CMC Regulatory Technical Writer
✨Tip Number 1
Familiarize yourself with the specific CMC regulatory requirements and guidelines, such as ICH, FDA, and EMA. This knowledge will not only help you understand the expectations for the role but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in CMC regulatory submissions. Engaging with others in the field can provide valuable insights and potentially lead to referrals or recommendations.
✨Tip Number 3
Showcase your technical writing skills by preparing a portfolio of relevant documents you've worked on in the past. Highlight your ability to communicate complex scientific information clearly and effectively, as this is crucial for the role.
✨Tip Number 4
Stay organized and be prepared to discuss your project management experience during the interview. Being able to handle multiple tasks simultaneously is key in this role, so share examples of how you've successfully managed timelines and deliverables in previous positions.
We think you need these skills to ace Senior CMC Regulatory Technical Writer
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly understand the responsibilities and qualifications outlined in the job description. Highlight your relevant experience in CMC regulatory writing and how it aligns with the requirements.
Tailor Your CV: Customize your CV to emphasize your technical writing skills and experience in CMC roles. Include specific examples of regulatory documents you have prepared, especially those related to late-stage clinical applications and eCTD submissions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory science and your meticulous attention to detail. Mention your familiarity with ICH, FDA, and EMA guidelines, and explain how your background makes you a perfect fit for the team.
Proofread and Edit: Before submitting your application, carefully proofread all documents to ensure there are no errors. Pay special attention to clarity and consistency, as these are crucial in regulatory writing.
How to prepare for a job interview at RBW Consulting
✨Showcase Your Technical Writing Skills
Prepare to discuss your previous experience in technical writing, especially in the context of CMC regulatory submissions. Bring examples of documents you've written, particularly those related to Modules 2.3 and 3 of the CTD, to demonstrate your expertise.
✨Understand Regulatory Guidelines
Familiarize yourself with the latest ICH, FDA, and EMA guidelines relevant to CMC submissions. Be ready to discuss how you have applied these guidelines in your past roles and how you stay updated on regulatory changes.
✨Highlight Collaboration Experience
Emphasize your ability to work collaboratively with cross-functional teams. Prepare examples of how you've gathered information from formulation, process development, and manufacturing teams to create comprehensive regulatory documents.
✨Demonstrate Project Management Skills
Be prepared to discuss how you manage timelines and deliverables for multiple projects. Share specific strategies you use to ensure accuracy and completeness in your submissions while communicating potential delays effectively.
