Associate Director, Regulatory Affairs CMC

Social network you want to login/join with:Associate Director, Regulatory Affairs CMC, yorkcol-narrow-leftClient:AL SolutionsLocation:Job Category:Other-EU work permit required:Yescol-narrow-rightJob Views:1Posted:31.05.2025Expiry Date:15.07.2025col-wideJob 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 stagesServe as the primary regulatory point of contact for client projects and Health Authority interactionsOversee preparation, review, and submission of INDs, IMPDs, BLAs, MAAs, variations, and supplementsContribute to internal regulatory intelligence and advise cross-functional teams on evolving regulatory expectationsSupport strategic client engagements, including proposal development and consultation meetingsMentor and guide junior regulatory team members on CMC-related mattersYour 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 lifecycleStrong scientific understanding of drug development, manufacturing, and quality systemsPrevious experience in a consultancy, CRO, or agile biotech environment is highly desirableExcellent communication and stakeholder management skills, including client-facing interactionsEU-based preferred, but global applicants with relevant experience will be consideredWhat’s On Offer:Associate Director-level role with strategic influence across multiple client programsFully remote, flexible working environmentExposure to cutting-edge biologics and global regulatory frameworksCareer progression in a collaborative, fast-paced consultancyOpportunity to work with top-tier clients across the EU and US markets #J-18808-Ljbffr