Job Title

IntroductionBrunel is recruiting a Director, Regulatory Affairs CMC Biologics to provide strategic and operational leadership across biologics programs throughout the product lifecycle. This is a full-time permanent opportunity working fully remote in Canada.This is a seniorlevel consulting role suited for an experienced Regulatory Affairs professional with deep CMC biologics expertise, strong clientfacing skills, and the ability to lead complex global submissions while mentoring teams.ResponsibilitiesLead and oversee all CMC regulatory activities for biologics programs across clinical development and commercializationProvide strategic regulatory CMC guidance to internal teams and external clientsAuthor, review, and oversee CMC sections (Module 3 and Module 2.3) for CTAs, INDs, NDSs, NDAs, BLAs, and NSNsSupport and participate in health authority interactions with FDA, Health Canada, and other global agenciesManage postapproval changes and lifecycle management strategiesPartner with crossfunctional teams, CROs, CMOs, and sponsors to deliver highquality regulatory outcomesAct as a trusted client contact, supporting project scoping, quoting, deliverable review, and timeline managementLead multiple projects simultaneously, balancing priorities in a fastpaced consulting environmentContribute to the development of internal SOPs, job aids, and best practicesMentor and develop regulatory team members through coaching and leadershipRequirementsBachelors degree or higher in biological, pharmaceutical, chemical, engineering sciences, or a related field1015 years of direct CMC Regulatory Affairs experience, with a strong focus on biologicsProven experience authoring and/or reviewing Module 3, and supporting or leading health authority interactionsPrior experience in regulatory consulting and/or leadership rolesHandson experience across submission types, including:CTAs, INDs, NDSs, NDAs, and BLAsStrong knowledge of drug substance and drug product CMC requirementsExpertise in control strategy, specifications, stability, analytical methods, validation, comparability, and viral safetySolid understanding of FDA and Health Canada CMC requirementsFamiliarity with Environment Canada New Substances RegulationsStrong project and people leadership skillsStrategic mindset with practical problemsolving ability for complex regulatory challengesComfortable working in crossfunctional and clientfacing environmentsHighly organized, detailoriented, and reliable under tight deadlinesExcellent written, verbal, and presentation skillsProficient in Microsoft Word, Excel, PowerPoint, and Office toolsWhy work with Brunel?We proudly offer exciting career opportunities through more than 120 offices across 45 countries. Advancing your career takes time and effort let Brunel connect you with the right opportunity.About UsBrunel has built a strong reputation by working with some of the best organizations globally. With over 50 years of experience across Mining, Renewable Energy, Oil & Gas, Life Sciences, Automotive, Infrastructure, and IT, we provide the recruitment and workforce solutions needed to deliver projects safely, compliantly, on time, and within budget anywhere in the world.