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- Tasks: Lead regulatory strategy and author CMC sections for innovative oncology and neurology products.
- Company: Established pharmaceutical company focused on cutting-edge science in Oncology and Neurology.
- Benefits: Competitive salary, bonus, car allowance, life assurance, pension scheme, and private healthcare.
- Why this job: Join a dynamic team and make a real impact in global regulatory processes.
- Qualifications: Bachelor's degree in a scientific field; 6-10 years of regulatory CMC experience required.
- Other info: Excellent career progression opportunities in a supportive environment.
The predicted salary is between 48000 - 72000 £ per year.
An exciting opportunity to join an established pharmaceutical company that specialises in Oncology and Neurology. The role will be working across both portfolios and will have a heavy focus on regulatory strategy. As a Regulatory Affairs, CMC lead for developing programs, this is an exciting opportunity to demonstrate your knowledge in managing regulatory processes from authoring CMC sections for developing biological/Small Molecule products, including working as an SME for RA CMC processes.
A great opportunity to demonstrate your knowledge in leading regulatory processes for products across the globe, with a focus on oncology and neurology. In this unique position, you will interact with a wide and diverse range of colleagues across the organization.
Key Responsibilities- Support regulatory CMC writing activities including authoring CMC sections in development including, CTA, IND, BLA, NDA, IMPD, and MAA.
- Lead preparation of submission dossiers. This includes reviewing CTD dossiers such as M3/source documents, and authoring of QOS (M2.3), as well as creating of RtQs from Health Authority as needed.
- The position will be focused on CMC and will need a good understanding of CMC lifecycle maintenance activities across EU and international markets.
- Supporting global CMC regulatory strategy including working cross-functional with key stakeholders inside and outside the organisation.
- Prepare and coordinate the review and approval of submission-ready documents.
- Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations.
- Minimum of a Bachelor's degree in a Scientific or Technical Discipline; Advanced Degree (MS, Ph.D.) preferred.
- A highly specialized individual contributor with advanced CMC regulatory knowledge and expertise in a professional discipline.
- 6-10 years of CORE regulatory CMC experience, ideally in both small and large molecules.
- Must have previous experience authoring Regulatory Clinical CMC sections for EU/US submissions.
- Change Control assessment experience (application of relevant regulatory guidance to proposed change).
This is an excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development. You will be supported by an established CMC team providing excellent career progression opportunities and a chance to work as a senior figure in the RA CMC team. The role comes with some excellent benefits, including a bonus, car allowance, life assurance, pension scheme, and private healthcare.
This role does not provide sponsorship, and you must have the Right to Work in the UK.
For more details about this position please feel free to contact lucy.kirkaldy@cpl.com.
Associate Director, Regulatory Affairs CMC in London employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Regulatory Affairs CMC in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your CMC knowledge. Be ready to discuss your experience with authoring CMC sections and leading regulatory processes. Show them you’re the go-to person for all things CMC!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your career goals. Use our website to find roles that excite you and match your expertise in oncology and neurology.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. Mention something specific from your conversation to show you were engaged and are genuinely interested in the role.
We think you need these skills to ace Associate Director, Regulatory Affairs CMC in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director role. Highlight your experience in regulatory CMC, especially with biologics and small molecules. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs in oncology and neurology. Let us know how your background makes you the perfect fit for our team.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Whether it's successful submissions or leading cross-functional teams, we love to see how you've made an impact in your previous roles.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC regulatory processes, especially for biologics and small molecules. Be ready to discuss your experience with authoring CMC sections and how you've navigated the complexities of submissions like INDs and BLAs.
✨Showcase Your Strategic Thinking
This role requires a strong focus on regulatory strategy. Prepare examples of how you've developed and implemented successful regulatory strategies in previous roles, particularly in oncology or neurology. Highlight your ability to work cross-functionally with stakeholders.
✨Be Ready for Technical Questions
Expect some technical questions related to CMC lifecycle maintenance and regulatory requirements. Brush up on relevant regulations and be prepared to discuss how you've applied them in real-world scenarios. This will show your depth of knowledge and expertise.
✨Demonstrate Your Leadership Skills
As an Associate Director, you'll need to lead and mentor others. Think of examples where you've taken charge of projects or guided teams through complex regulatory processes. Show that you're not just a specialist but also a leader who can inspire and support others.
