Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead CMC regulatory activities and author key documentation for global submissions.
- Company: Global regulatory consulting organisation with a focus on pharmaceutical and biotech clients.
- Benefits: Competitive salary, professional development, and opportunities to work with industry experts.
- Why this job: Make a significant impact in the pharmaceutical industry while collaborating with cross-functional teams.
- Qualifications: 9-15 years of experience in CMC Regulatory Affairs and a degree in a scientific discipline.
- Other info: Join a dynamic team and advance your career in a vital sector.
The predicted salary is between 54000 - 84000 £ per year.
We're currently working with a global regulatory consulting organisation to hire an Associate Director – Regulatory Affairs CMC. This role will support pharmaceutical and biotech clients with CMC regulatory strategy across development and lifecycle programs.
Key Responsibilities
- Lead CMC regulatory activities across product development and lifecycle management.
- Author and review CMC regulatory documentation and CTD Module 3 for global submissions (IND/IMPD/CTA/NDA/BLA/MAA).
- Support CMC regulatory strategy, Health Authority interactions, and post-approval change management.
- Act as a client-facing regulatory expert working with cross-functional teams.
Requirements
- 9–12 years’ experience (Senior Manager) or 12–15 years’ experience (Associate Director) in CMC Regulatory Affairs.
- Strong experience supporting CMC development and regulatory submissions.
- Knowledge of EU and/or US CMC regulatory requirements and ICH guidelines.
- Degree in a scientific discipline.
Associate Director Regulatory Affairs employer: Scienta
Contact Detail:
Scienta Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space, especially those who have experience with CMC. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU and US CMC regulatory requirements. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Showcase your client-facing skills! In your conversations, highlight your experience working with cross-functional teams and how you've successfully managed client relationships in the past.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of resources to help you land that Associate Director role, and applying directly can give you an edge over the competition.
We think you need these skills to ace Associate Director Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director – Regulatory Affairs role. Highlight your experience in CMC regulatory activities and any relevant projects you've led. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Share specific examples of your experience with CMC regulatory submissions and how you’ve successfully navigated Health Authority interactions.
Showcase Your Expertise: Don’t hold back on showcasing your expertise in EU and US CMC regulatory requirements. We’re looking for someone who can hit the ground running, so make sure to mention any relevant guidelines or regulations you’re familiar with.
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 Scienta
✨Know Your CMC Inside Out
Make sure you brush up on your knowledge of CMC regulatory requirements and ICH guidelines. Be prepared to discuss specific examples from your past experience where you've successfully navigated these regulations, as this will show your expertise and confidence in the field.
✨Showcase Your Leadership Skills
As an Associate Director, you'll be leading CMC regulatory activities. Think of instances where you've led cross-functional teams or managed complex projects. Highlight your leadership style and how it has positively impacted your previous roles.
✨Prepare for Client-Facing Scenarios
Since this role involves acting as a client-facing regulatory expert, prepare for questions about how you handle client interactions. Consider discussing a challenging client situation and how you resolved it, demonstrating your communication skills and ability to build relationships.
✨Familiarise Yourself with Global Submissions
Get comfortable with the specifics of global submissions like IND, IMPD, CTA, NDA, BLA, and MAA. Be ready to talk about your experience with authoring and reviewing CMC regulatory documentation, as this will be crucial for the role.