Regulatory Affairs Consultant

CMC Regulatory Consultant (6-12 Month Contract // REMOTE) Part-time - 10-20+ hours per weekSummary: CMC Regulatory Expert needed to support INDa submission activities and related responsibilitiesDuties & Responsibilities: Provide Subject Matter Expert-level guidance for submission structure and contentReview submission draft for Module 3 compliance, overall accuracy and completeness, and provide overall CMC regulatory strategy guidanceProvide general feedback for IND filing and amendmentsCollaboration with internal stakeholders and other related personnelProvide submission readiness sign-offOther duties, as requiredQualifications & Requirements: Solid experience CMC Regulatory strategy, content and authoring expertise for viral vector or microbial systems Phase II INDa submissionsExtensive track record of managing, authoring and editing multiple FDA regulatory submissionsStrong understanding of biologics Chemistry, Manufacturing and Controls and related complianceExcellent written, verbal and interpersonal communication skillsRelevant degreeLocation: Work can be performed remotely from home