Regulatory Affairs CMC Lead - Cell & Gene Therapies
Regulatory Affairs CMC Lead - Cell & Gene Therapies

Regulatory Affairs CMC Lead - Cell & Gene Therapies

Full-Time 48000 - 72000 £ / year (est.) No home office possible
A

At a Glance

  • Tasks: Lead global regulatory strategies for innovative cell and gene therapies.
  • Company: Dynamic biopharmaceutical company focused on advancing cancer therapies.
  • Benefits: Collaborative work environment with opportunities for professional growth.
  • Why this job: Make a real difference in the fight against cancer through innovative therapies.
  • Qualifications: 8-10 years in Regulatory Affairs for biologics and strong communication skills.
  • Other info: Join a passionate team dedicated to transforming healthcare.

The predicted salary is between 48000 - 72000 £ per year.

A biopharmaceutical company in the UK seeks an experienced Associate Director, Regulatory Affairs CMC, responsible for leading global CMC regulatory strategies for its innovative cell and gene therapy products.

The ideal candidate will have 8-10 years of experience in Regulatory Affairs for biologics, excellent communication skills, and a proven track record in regulatory submissions and interactions with health authorities.

This role offers a dynamic work environment focused on teamwork and advancing cancer therapies.

Regulatory Affairs CMC Lead - Cell & Gene Therapies employer: Autolus Limited

As a leading biopharmaceutical company in the UK, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to make a meaningful impact in the field of cell and gene therapies. We offer competitive benefits, continuous professional development opportunities, and a supportive environment that encourages teamwork and creativity, making us an excellent employer for those passionate about advancing healthcare solutions.
A

Contact Detail:

Autolus Limited Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Regulatory Affairs CMC Lead - Cell & Gene Therapies

✨Tip Number 1

Network like a pro! Reach out to professionals in the regulatory affairs space, especially those who have experience with cell and gene therapies. LinkedIn is a great platform for this – don’t be shy to send a message and ask for a chat!

✨Tip Number 2

Prepare for interviews by brushing up on your knowledge of CMC regulations and recent developments in the field. We recommend creating a cheat sheet of key points to discuss, so you can showcase your expertise confidently.

✨Tip Number 3

Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and get comfortable discussing your experience in regulatory submissions. This will help you stand out during the real deal.

✨Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!

We think you need these skills to ace Regulatory Affairs CMC Lead - Cell & Gene Therapies

Regulatory Affairs
CMC (Chemistry, Manufacturing and Controls)
Biologics
Regulatory Submissions
Health Authority Interactions
Communication Skills
Teamwork
Project Management
Cell and Gene Therapies
Problem-Solving Skills
Strategic Planning
Attention to Detail
Adaptability
Leadership

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, especially with biologics. We want to see how your background aligns with the role of CMC Lead for cell and gene therapies.

Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about advancing cancer therapies and how your skills can contribute to our team. Keep it engaging and relevant!

Showcase Your Communication Skills: Since excellent communication is key for this role, make sure your application reflects that. Use clear, concise language and structure your documents well. We love a good flow!

Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!

How to prepare for a job interview at Autolus Limited

✨Know Your CMC Inside Out

Make sure you brush up on your knowledge of Chemistry, Manufacturing, and Controls (CMC) specific to cell and gene therapies. Be ready to discuss your previous experiences with regulatory submissions and how you've navigated interactions with health authorities.

✨Showcase Your Communication Skills

Since excellent communication is key for this role, prepare examples that highlight your ability to convey complex regulatory information clearly. Think about times when you successfully communicated with cross-functional teams or presented to stakeholders.

✨Demonstrate Teamwork

This position emphasises a dynamic work environment focused on teamwork. Be prepared to share specific instances where you collaborated effectively with others, especially in high-pressure situations related to regulatory affairs.

✨Stay Updated on Industry Trends

Familiarise yourself with the latest trends and regulations in the biopharmaceutical industry, particularly around cell and gene therapies. Showing that you're proactive about staying informed will impress your interviewers and demonstrate your commitment to the field.

Regulatory Affairs CMC Lead - Cell & Gene Therapies
Autolus Limited

Land your dream job quicker with Premium

You’re marked as a top applicant with our partner companies
Individual CV and cover letter feedback including tailoring to specific job roles
Be among the first applications for new jobs with our AI application
1:1 support and career advice from our career coaches
Go Premium

Money-back if you don't land a job in 6-months

A
Similar positions in other companies
UK’s top job board for Gen Z
discover-jobs-cta
Discover now
>