Job Title

Introduction Brunel 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. Responsibilities - Lead and oversee all CMC regulatory activities for biologics programs across clinical development and commercialization - Provide strategic regulatory CMC guidance to internal teams and external clients - Author, review, and oversee CMC sections (Module 3 and Module 2.3) for CTAs, INDs, NDSs, NDAs, BLAs, and NSNs - Support and participate in health authority interactions with FDA, Health Canada, and other global agencies - Manage postapproval changes and lifecycle management strategies - Partner with crossfunctional teams, CROs, CMOs, and sponsors to deliver highquality regulatory outcomes - Act as a trusted client contact, supporting project scoping, quoting, deliverable review, and timeline management - Lead multiple projects simultaneously, balancing priorities in a fastpaced consulting environment - Contribute to the development of internal SOPs, job aids, and best practices - Mentor and develop regulatory team members through coaching and leadership Requirements - Bachelors degree or higher in biological, pharmaceutical, chemical, engineering sciences, or a related field - 1015 years of direct CMC Regulatory Affairs experience, with a strong focus on biologics - Proven experience authoring and/or reviewing Module 3, and supporting or leading health authority interactions - Prior experience in regulatory consulting and/or leadership roles - Handson experience across submission types, including: - CTAs, INDs, NDSs, NDAs, and BLAs - Strong knowledge of drug substance and drug product CMC requirements - Expertise in control strategy, specifications, stability, analytical methods, validation, comparability, and viral safety - Solid understanding of FDA and Health Canada CMC requirements - Familiarity with Environment Canada New Substances Regulations - Strong project and people leadership skills - Strategic mindset with practical problemsolving ability for complex regulatory challenges - Comfortable working in crossfunctional and clientfacing environments - Highly organized, detailoriented, and reliable under tight deadlines - Excellent written, verbal, and presentation skills - Proficient in Microsoft Word, Excel, PowerPoint, and Office tools Why 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 Us Brunel 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.