Associate Director, Regulatory Affairs CMC - #1765633
AL Solutions
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. m
Abs, 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 interactionsEU-based preferred, but global applicants with relevant experience will be considered
Fluent in EnglishWhat’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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