At a Glance
- Tasks: Craft high-quality regulatory documents for Chemistry, Manufacturing, and Controls (CMC) submissions.
- Company: Join a leading life sciences recruiter with a focus on innovation.
- Benefits: Fully remote role offering flexibility and work-life balance.
- Other info: Collaborative environment with opportunities to engage with regulatory agencies.
- Why this job: Make a real impact in the life sciences field while working from anywhere.
- Qualifications: Background in Life Sciences or related field; CMC regulatory writing experience preferred.
The predicted salary is between 36000 - 60000 £ per year.
Shape your future with the freedom to work where you thrive! Join our client in this fully remote role that fits your life.
Proclinical is seeking a detail-oriented Regulatory Affairs CMC Writer to support the preparation of high-quality Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions. This role focuses on authoring key sections of regulatory documents, including Module 2.3 (Quality Overall Summary), Module 3 (Quality), and CMC-specific content for Briefing Books used in Scientific Advice procedures with regulatory agencies.
Responsibilities:
- Draft and revise Module 2.3 (Quality Overall Summary) to ensure alignment with Module 3 and compliance with ICH guidelines.
- Prepare and update Module 3 (Quality) sections, covering drug substance, drug product, and control strategies based on source data and development reports.
- Author CMC-specific content for Briefing Books submitted to regulatory authorities for Scientific Advice procedures.
- Ensure all documents meet internal standards and regulatory requirements (e.g., EMA, FDA, ICH).
- Collaborate with internal CMC experts, QA, Regulatory Affairs, and external manufacturing partners to gather technical information.
- Align content across modules to maintain scientific consistency and regulatory clarity.
- Support regulatory strategy by providing scientifically sound CMC documentation aligned with the overall development plan.
- Contribute to responses to agency questions or follow-ups related to CMC topics.
Key Skills and Requirements:
- Background in Life Sciences, Chemistry, Pharmacy, or a related field (advanced degree preferred).
- Experience in CMC regulatory writing, including preparation of Modules 2.3, 3, and CMC sections of Briefing Books for EU and/or US regulatory submissions.
- Strong knowledge of ICH guidelines and EMA/FDA CMC requirements, including eCTD submission formats.
- Excellent writing, analytical, and communication skills in English.
- Ability to work independently in a remote or virtual team environment.
- High attention to detail with a focus on document structure and scientific clarity.
- Familiarity with document management systems and collaborative writing tools (e.g., Veeva, SharePoint) is a plus.
- Experience with biologics, cell and gene therapy, or complex injectables is advantageous.
- Prior engagement with regulatory agencies (e.g., EMA, FDA, MHRA) is preferred.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click \'Apply\' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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Regulatory CMC Writer in England employer: Proclinical Staffing
Proclinical offers an exceptional remote working environment that empowers Regulatory CMC Writers to thrive in their careers while enjoying the flexibility of working from anywhere. With a strong focus on employee growth, Proclinical provides opportunities for professional development and collaboration with industry experts, ensuring that you are well-equipped to contribute to high-quality regulatory submissions. Join a culture that values detail-oriented work and scientific clarity, making a meaningful impact in the life sciences sector.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory CMC Writer in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for virtual interviews by practising common questions related to CMC writing. Make sure you can confidently discuss your experience with Modules 2.3 and 3, as well as your knowledge of ICH guidelines.
✨Tip Number 3
Showcase your expertise! Create a portfolio of your best CMC documents and be ready to share them during interviews. This will demonstrate your skills and give potential employers a taste of what you can bring to the table.
✨Tip Number 4
Don't forget to apply through our website! It’s the easiest way to get your application noticed. Plus, we’re here to help you every step of the way, so don’t hesitate to reach out if you need assistance.
We think you need these skills to ace Regulatory CMC Writer in England
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Regulatory CMC Writer role. Highlight your experience with Modules 2.3 and 3, and any relevant knowledge of ICH guidelines. We want to see how your background fits perfectly with what we're looking for!
Showcase Your Writing Skills:Since this role is all about writing high-quality documentation, include examples of your previous work if possible. We love seeing clear, concise writing that demonstrates your ability to communicate complex information effectively.
Highlight Collaboration Experience:This position involves working with various teams, so mention any past experiences where you collaborated with CMC experts or regulatory affairs. We value teamwork, and showing us how you thrive in a collaborative environment will definitely catch our eye!
Apply Through Our Website:Don't forget to apply through our website! It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about us and what we do!
How to prepare for a job interview at Proclinical Staffing
✨Know Your Modules Inside Out
Make sure you’re well-versed in the specifics of Module 2.3 and Module 3. Brush up on ICH guidelines and be ready to discuss how your experience aligns with these requirements. This will show that you’re not just familiar with the content but can also contribute meaningfully.
✨Showcase Your Attention to Detail
As a Regulatory CMC Writer, attention to detail is crucial. Prepare examples from your past work where your meticulousness made a difference. Whether it’s catching a minor error or ensuring compliance, highlight how your thoroughness has positively impacted your projects.
✨Familiarise Yourself with Collaborative Tools
Since this role is remote, being comfortable with document management systems like Veeva or SharePoint can set you apart. If you’ve used these tools before, mention specific instances where they helped streamline your writing process or improve collaboration.
✨Prepare for Regulatory Agency Interactions
If you have prior experience engaging with regulatory agencies, be ready to discuss it. Think about how you handled questions or follow-ups related to CMC topics. This will demonstrate your ability to navigate complex regulatory landscapes and your readiness for the role.
