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- Tasks: Prepare and submit high-quality CMC regulatory documents for clinical and marketing applications.
- Company: Join a dynamic Regulatory Department focused on innovative biopharmaceuticals.
- Benefits: Freelance position with potential renewal until March 2025, offering flexibility.
- Why this job: Be part of impactful regulatory science and collaborate with diverse teams.
- Qualifications: Degree in Pharmacy or related field; detail-oriented with strong writing skills.
- Other info: Opportunity to guide and train team members while managing multiple projects.
The predicted salary is between 36000 - 60000 £ per year.
Technical Writer – Analytical CMC Are you a detail-oriented technical writer with a passion for regulatory science and analytical development? Join a dynamic 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. This is a freelance position until March 2025 – although it is likely to be renewed. 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…
Technical Writer - Analytical CMC employer: RBW Consulting
Contact Detail:
RBW Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Technical Writer - Analytical CMC
✨Tip Number 1
Familiarize yourself with the specific regulatory guidelines and requirements for CMC submissions. Understanding the nuances of Modules 2.3 and 3 of the CTD will give you a significant edge in discussions with potential employers.
✨Tip Number 2
Network with professionals in the regulatory science field, especially those who have experience in analytical development. Engaging with industry experts can provide insights into the role and may lead to valuable referrals.
✨Tip Number 3
Showcase your ability to manage multiple projects and meet tight deadlines. Highlight any past experiences where you successfully oversaw timelines and deliverables, as this is crucial for the role.
✨Tip Number 4
Prepare to discuss your collaborative skills during interviews. Be ready to share examples of how you've worked with cross-functional teams to gather information and ensure compliance in regulatory documents.
We think you need these skills to ace Technical Writer - Analytical CMC
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Technical Writer - Analytical CMC position. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in regulatory writing, particularly with CMC sections of regulatory submissions. Provide specific examples of documents you've prepared or projects you've managed that align with the job requirements.
Showcase Collaboration Skills: Since the role involves collaboration with various CMC teams, mention any relevant teamwork experiences. Highlight how you have successfully worked with cross-functional teams to gather information and meet project deadlines.
Proofread Your Application: Before submitting your application, carefully proofread all documents for clarity, accuracy, and consistency. Given the detail-oriented nature of the role, a polished application will demonstrate your attention to detail.
How to prepare for a job interview at RBW Consulting
✨Showcase Your Attention to Detail
As a technical writer, attention to detail is crucial. Be prepared to discuss specific examples from your past work where your meticulousness led to successful outcomes in regulatory submissions.
✨Familiarize Yourself with Regulatory Guidelines
Make sure you understand the key regulatory guidelines relevant to CMC submissions, especially Modules 2.3 and 3 of the CTD. Being able to speak knowledgeably about these will demonstrate your expertise and readiness for the role.
✨Highlight Collaborative Experiences
Collaboration is key in this role. Prepare to share experiences where you worked closely with cross-functional teams, such as formulation or process development, to gather information for regulatory documents.
✨Discuss Project Management Skills
Since managing timelines and deliverables is part of the job, be ready to talk about how you've successfully managed multiple projects in the past. Highlight any tools or methods you used to keep everything on track.
