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- Tasks: Lead regulatory strategy for biologics and advanced therapies in a dynamic consultancy.
- Company: Join a fast-growing life sciences consultancy making waves in the biotech industry.
- Benefits: Enjoy a fully remote role with flexible working hours and career progression opportunities.
- Why this job: Make a strategic impact while working with top-tier clients and cutting-edge projects.
- Qualifications: 8-12 years in CMC Regulatory Affairs with strong biologics expertise required.
- Other info: Ideal for experienced professionals looking to mentor junior team members.
The predicted salary is between 54000 - 84000 £ per year.
A fast-growing and forward-thinking life sciences consultancy is seeking an Associate Director of Regulatory Affairs – CMC to lead regulatory strategy and execution across a dynamic portfolio of biologic and advanced therapy programs. This fully remote opportunity is ideal for an experienced, client-facing regulatory professional ready to make a broader strategic impact.
As an Associate Director, you will work directly with biotech clients across early- and late-stage development, taking the lead on CMC regulatory activities and guiding project teams through global regulatory pathways.
Key Responsibilities:- Lead the development and implementation of CMC regulatory strategies for biologics across development and post-approval stages
- Serve as the primary regulatory point of contact for client projects and Health Authority interactions
- Oversee preparation, review, and submission of INDs, IMPDs, BLAs, MAAs, variations, and supplements
- Contribute to internal regulatory intelligence and advise cross-functional teams on evolving regulatory expectations
- Support strategic client engagements, including proposal development and consultation meetings
- Mentor and guide junior regulatory team members on CMC-related matters
- 8–12 years of experience in CMC Regulatory Affairs, with strong biologics expertise (e.g. mAbs, cell/gene therapy, ATMPs)
- Proven track record leading global submissions across the product lifecycle
- Strong scientific understanding of drug development, manufacturing, and quality systems
- Previous experience in a consultancy, CRO, or agile biotech environment is highly desirable
- Excellent communication and stakeholder management skills, including client-facing interactions
- EU-based preferred, but global applicants with relevant experience will be considered
- Fluent in English
- Associate Director-level role with strategic influence across multiple client programs
- Fully remote, flexible working environment
- Exposure to cutting-edge biologics and global regulatory frameworks
- Career progression in a collaborative, fast-paced consultancy
- Opportunity to work with top-tier clients across the EU and US markets
Locations
Associate Director, Regulatory Affairs CMC employer: AL Solutions
Contact Detail:
AL Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Regulatory Affairs CMC
✨Tip Number 1
Network with professionals in the life sciences and regulatory affairs sectors. Attend industry conferences, webinars, and workshops to connect with potential colleagues and clients. Building relationships can lead to valuable insights and job opportunities.
✨Tip Number 2
Stay updated on the latest regulatory changes and trends in biologics and advanced therapies. Subscribe to relevant journals, follow key thought leaders on social media, and participate in online forums to demonstrate your knowledge during interviews.
✨Tip Number 3
Prepare for client-facing scenarios by practising your communication skills. Role-play common regulatory discussions or presentations with a friend or mentor to build confidence and ensure you can articulate your strategies clearly.
✨Tip Number 4
Research StudySmarter and our approach to regulatory affairs. Familiarise yourself with our projects and values so you can align your experience and aspirations with what we do, making a strong case for why you’d be a great fit for the team.
We think you need these skills to ace Associate Director, Regulatory Affairs CMC
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your 8–12 years of experience in CMC Regulatory Affairs, focusing on your expertise with biologics and any relevant projects you've led. Use specific examples to demonstrate your impact in previous roles.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Discuss your experience with global submissions and how it aligns with the responsibilities of the Associate Director position. Mention your client-facing skills and how you can contribute to strategic client engagements.
Highlight Relevant Achievements: When detailing your experience, focus on specific achievements related to CMC regulatory activities. Include metrics or outcomes where possible, such as successful submissions or improvements in regulatory processes that you have implemented.
Showcase Communication Skills: Since excellent communication is key for this role, provide examples of how you've effectively managed stakeholder relationships or led cross-functional teams. This will demonstrate your ability to serve as the primary regulatory point of contact for clients.
How to prepare for a job interview at AL Solutions
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive experience in CMC Regulatory Affairs, especially with biologics. Be prepared to discuss specific projects where you led global submissions and how you navigated complex regulatory pathways.
✨Demonstrate Client-Facing Skills
Since this role involves direct interaction with clients, share examples of how you've successfully managed client relationships in the past. Emphasise your communication skills and ability to guide clients through regulatory processes.
✨Prepare for Technical Questions
Expect questions that assess your scientific understanding of drug development and manufacturing. Brush up on key concepts related to biologics, including mAbs and ATMPs, so you can confidently answer any technical queries.
✨Discuss Mentorship Experience
As a potential mentor for junior team members, be ready to talk about your experience in guiding others. Share specific instances where you provided support or training, demonstrating your leadership capabilities within a regulatory context.
