Regulatory Affairs Consultant CMC

About the OpportunityOur client is a growing biopharmaceutical company advancing a biologics pipeline through late stage development and toward commercialization. To support an active submission timeline, they are engaging an experienced Regulatory Affairs CMC professional on a consulting basis to lead CMC authoring, strategy, and lifecycle management work.This is a hands on engagement for someone who is equally comfortable setting CMC regulatory strategy and doing the technical writing themselves, without a team underneath them.Role SummaryThe Regulatory Affairs CMC Consultant will provide strategic and hands on support for Chemistry, Manufacturing, and Controls regulatory activities across the product lifecycle. The role covers CMC regulatory strategy, authoring and review of CMC submission content, and lifecycle and change management support to enable global filings and maintain inspection ready documentation.This person will report to the Executive Director of RA CMC and will work closely with Analytical Development, Quality Control, Manufacturing and Technical Operations, and external contract manufacturing partners.Key ResponsibilitiesLead planning, compilation, and authoring of CTD Module 3 (Quality) content for global submissions (IND/IMPD, NDA/BLA, MAA), including lifecycle maintenance submissions and responses to health authority questions.Develop and communicate phase appropriate CMC regulatory strategy and filing approach, including risk identification and mitigation recommendations.Assess, document, and manage CMC changes through Change Control, including regulatory impact assessments, categorization and filing strategy, and alignment of quality systems documentation with submission content.Provide regulatory oversight of CMC technical packages, including stability protocols and reports, analytical methods and validation, specifications, manufacturing processes and controls, and comparability plans.Lead cross functional working sessions with R&D, Analytical, QC, Manufacturing and Technical Operations, and QA to define CMC deliverables, owners, and timelines.Support submission ready content for Drug Substance (3.2.S) and Drug Product (3.2.P) sections, ensuring internal consistency across specifications, methods, and batch data.Attend and support CMC meetings with external contract manufacturing organizations, including data requests, technical issue resolution, and change planning.Contribute to CMC briefing packages, information requests, and deficiency responses for health authority interactions.Coordinate cross functional document review cycles, adjudicate comments, and drive approvals while maintaining version control.Provide day to day guidance and technical review for junior RA CMC staff or contractors, as needed.QualificationsAdvanced degree in a scientific discipline (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field) preferred; equivalent experience considered.15 or more years of experience in the pharmaceutical industry, with significant experience in Regulatory Affairs CMC for biologics and at least 5 years in manufacturing or analytical sciences and QC.Demonstrated track record authoring and maintaining CTD Module 3 content for global submissions.Strong working knowledge of FDA, EMA, and ICH CMC requirements and expectations across development phases.Experience supporting late stage and/or commercial submissions, post approval CMC changes, and global lifecycle management.Experience with change control systems and regulatory impact assessments for manufacturing and analytical changes.Experience partnering with external manufacturers (CMOs), testing labs, or global sites, including data collection and oversight.Direct experience in health authority meetings or teleconferences and in responding to CMC related questions.Proven ability to lead cross functional teams and deliver high quality technical and regulatory documents with minimal supervision.Strong proficiency with Veeva, SharePoint, Microsoft Word, and Adobe Acrobat.Excellent scientific writing, editing, and communication skills, with the ability to synthesize complex CMC data into clear regulatory narratives.