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- Tasks: Lead regulatory strategy and author CMC sections for innovative biologics.
- Company: Established pharmaceutical company focused on Oncology and Neurology.
- Benefits: Competitive salary, bonus, car allowance, life assurance, pension, and private healthcare.
- Why this job: Make a real impact in global regulatory processes and advance your career in a dynamic team.
- Qualifications: Bachelor's degree in a scientific field; 6-10 years of regulatory CMC experience required.
- Other info: Join a supportive team with excellent career progression opportunities.
The predicted salary is between 43200 - 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 programmes, 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. You will interact with a wide and diverse range of colleagues across the organisation.
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, including reviewing CTD dossiers such as M3/source documents, and authoring of QOS (M2.3), as well as creating RtQs from Health Authority as needed.
- Focus on CMC lifecycle maintenance activities across EU and international markets.
- Support 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.
Experience
- 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.
- 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.
Associate Director, Regulatory Affairs CMC in England 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 England
✨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 and recent regulatory changes. We recommend practising common interview questions and having examples ready that showcase your experience in authoring CMC sections.
✨Tip Number 3
Don’t just apply and wait! Follow up on your applications after a week or so. A quick email to express your continued interest can keep you on their radar and show your enthusiasm for the role.
✨Tip Number 4
Check out our website for the latest job openings. We regularly update our listings, and applying directly through us can give you a better chance of landing that dream role in regulatory affairs!
We think you need these skills to ace Associate Director, Regulatory Affairs CMC in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director role. Highlight your CMC regulatory experience and any specific projects related to oncology or neurology. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your expertise can contribute to our team. Keep it engaging and relevant to the job description.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements in previous roles. Whether it’s successful submissions or leading cross-functional teams, we love to see how you’ve made an impact in your past positions.
Apply Through Our Website: We encourage you to apply through our website for a smoother application 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 for submissions like INDs and BLAs, as this will show your expertise and confidence in the field.
✨Showcase Your Strategic Thinking
This role has a heavy focus on regulatory strategy, so be prepared to share examples of how you've developed and implemented successful regulatory strategies in the past. Think about specific challenges you faced and how you navigated them, as this will demonstrate your problem-solving skills.
✨Engage with Cross-Functional Teams
Since you'll be working with diverse colleagues across the organisation, highlight your experience in collaborating with different teams. Share stories that illustrate your ability to communicate effectively and build relationships, as this is crucial for success in this role.
✨Prepare for Regulatory Questions
Anticipate questions related to regulatory compliance and lifecycle maintenance activities. Familiarise yourself with the latest EU and international regulations, and be ready to discuss how you've ensured submissions are complete and accurate in your previous roles.
