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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 43200 - 72000 £ 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
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 who can provide insights into the role and company culture.
✨Tip Number 2
Stay updated on the latest trends and changes in CMC regulatory affairs, especially regarding biologics and advanced therapies. This knowledge will not only enhance your discussions during interviews but also demonstrate your commitment to the field.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully led regulatory submissions or navigated complex regulatory pathways. Highlighting these achievements will showcase your expertise and strategic thinking.
✨Tip Number 4
Familiarise yourself with the company's portfolio and their approach to client engagement. Tailoring your conversations to reflect an understanding of their work will help you stand out as a candidate who is genuinely interested in contributing to their success.
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 experience in CMC Regulatory Affairs, especially with biologics. Emphasise your leadership roles and any successful global submissions you've managed.
Craft a Compelling Cover Letter: In your cover letter, clearly articulate your understanding of the regulatory landscape for biologics. Mention specific examples of how you've led regulatory strategies and interacted with clients or health authorities.
Highlight Relevant Experience: When detailing your work history, focus on your 8-12 years of experience in CMC Regulatory Affairs. Include any consultancy or CRO experience, as well as your scientific understanding of drug development and quality systems.
Showcase Communication Skills: Since excellent communication is key for this role, provide examples of your client-facing interactions and stakeholder management. This could be through project descriptions or achievements that demonstrate your ability to engage effectively with diverse teams.
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.
