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- Tasks: Provide CMC-Regulatory support for biologic projects and strengthen scientific arguments in submissions.
- Company: Join Eisai EMEA, a leader in the pharmaceutical industry.
- Benefits: Competitive salary, hybrid working, learning opportunities, and well-being initiatives.
- Why this job: Make a real impact on biologic projects and collaborate with diverse teams.
- Qualifications: Bachelor’s degree in a Scientific or Technical Discipline; advanced degree preferred.
- Other info: Dynamic environment with opportunities for career growth and development.
The predicted salary is between 48000 - 72000 £ per year.
Join to apply for the Associate Director Biologics CMC Regulatory role at Eisai EMEA. As an Associate Director, you will provide CMC‑Regulatory support for biologic projects and approved products, including antibody drugs, from a global perspective. You will strengthen the science and scientific arguments in the Quality section of all submissions (IMPDs, INDs, briefings, BLAs/MAAs, variations, and renewal activities), provide CMC expertise at Health Authority meetings, collaborate with IPT and CMC teams (manufacturing/QA), and offer CMC input into Regulatory Submissions and Clinical Development Plans. You will proactively inform stakeholders about draft and new regulations/guidelines that could impact current projects.
Responsibilities
- Provide CMC‑Regulatory support on specific projects/queries.
- Strengthen scientific arguments in submissions.
- Represent the company at health authority meetings.
- Collaborate across teams to advance development projects.
- Inform stakeholders of regulatory changes.
What are we looking for?
- A bachelor’s degree (or equivalent with experience) in a Scientific or Technical Discipline; advanced degree (MSc, Ph.D., MBA) preferred.
- Extensive experience in the pharmaceutical industry with proven CMC regulatory support for new chemical entities and biologic products.
- Working knowledge of the development and manufacture of small molecules and biologics (mAbs) – including characterization, comparability, process validation, control strategy, and stability.
- Experience with multiple dosage form development and process validation.
- Good understanding of analytical aspects relevant to small molecules and biologics (mAbs), including specification setting and justification.
- Experience in regulatory submissions, agency interactions, CTD dossier/briefing document creation, and holding agency meetings on CMC/Quality issues.
What we offer in return
- Competitive salary and a comprehensive benefits package.
- Hybrid working (depending on role).
- Car/car allowance (depending on role).
- Electric charging points for electric/hybrid vehicles.
- Discretionary bonus.
- Free onsite parking.
- Subsidised onsite restaurant and coffee shop.
- Learning and development opportunities.
- Well‑being initiatives.
Associate Director Biologics CMC Regulatory employer: Eisai EMEA
Contact Detail:
Eisai EMEA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Biologics CMC Regulatory
✨Tip Number 1
Network like a pro! Reach out to professionals in the biologics and CMC regulatory space on LinkedIn. Join relevant groups and participate in discussions to get your name out there and show your expertise.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of current regulations and guidelines. We recommend creating a cheat sheet of key points to discuss, especially around CMC submissions and health authority interactions.
✨Tip Number 3
Don’t just wait for job openings to pop up! Keep an eye on our website and apply directly through it. This way, you’ll be among the first to know about new opportunities and can tailor your application to what we’re looking for.
✨Tip Number 4
Showcase your collaborative spirit! In your conversations, highlight examples of how you've worked with cross-functional teams. This is crucial in the CMC regulatory field, and we love to see candidates who can work well with others.
We think you need these skills to ace Associate Director Biologics CMC Regulatory
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director Biologics CMC Regulatory role. Highlight your relevant experience in CMC regulatory support and any specific projects that align with the job description. We want to see how your background fits perfectly 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 this role and how your skills can contribute to our team. Be sure to mention your experience with regulatory submissions and collaboration across teams, as these are key aspects of the position.
Showcase Your Expertise: In your application, don’t shy away from showcasing your expertise in biologics and small molecules. Discuss your knowledge of analytical aspects and any experience you have with health authority meetings. We love seeing candidates who can bring valuable insights to the table!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy and ensures your application goes directly to us. Plus, you’ll be one step closer to joining our fantastic team at Eisai EMEA!
How to prepare for a job interview at Eisai EMEA
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC regulatory processes, especially for biologics. Be ready to discuss specific examples from your past experience where you've strengthened scientific arguments in submissions or collaborated with cross-functional teams.
✨Prepare for Health Authority Meetings
Since you'll be representing the company at health authority meetings, practice articulating your thoughts clearly and confidently. Think about potential questions they might ask and prepare your responses, focusing on how your expertise can address their concerns.
✨Stay Updated on Regulations
Proactively inform yourself about the latest regulations and guidelines that could impact biologic projects. Bring this knowledge into the interview to demonstrate your commitment to staying ahead in the field and how you can help the company navigate these changes.
✨Showcase Your Collaborative Spirit
Collaboration is key in this role, so be prepared to share examples of how you've worked effectively with different teams in the past. Highlight your ability to communicate complex CMC issues clearly to non-experts, as this will be crucial in advancing development projects.