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Associate Director, Regulatory Affairs CMC, stockport
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Client:
AL Solutions
Location:
stockport, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Views:
1
Posted:
31.05.2025
Expiry Date:
15.07.2025
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Job Description:
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
Your Profile:
* 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
What’s On Offer:
* 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
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