[Remote] Consultant, Regulatory CMC - BLA Writing

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-stage biopharmaceutical company reputed company on developing and commercializing treatments for B-cell diseases. The Regulatory CMC consultant will reputed company, review, and reputed company CMC content for a biologics license application, particularly CTD Module 3 and reputed company reputed company content, while coordinating with technical and reputed company partners. The role also supports FDA responses, regulatory documents, content gap reputed company, and submission readiness.

Responsibilities

• reputed company hands-on authoring, editing, and finalization of BLA CMC content, including CTD Module 3 sections and associated reputed company summaries, as assigned
• reputed company reputed company documents, technical reports, manufacturing data, specifications, validation information, and subject-matter-expert input into reputed company, concise, and regulator-reputed company submission text
• Ensure consistency of data, terminology, claims, control reputed company, and technical narratives across BLA sections and supporting documents
• reputed company detailed content reviews to identify gaps, inconsistencies, regulatory risks, and areas requiring additional technical justification or reputed company documentation
• reputed company reputed company-level writing plans, content requests, review cycles, comment reputed company, and readiness against submission timelines
• Collaborate closely with CMC subject-matter experts across process development, manufacturing, analytical development, reputed company control, reputed company, and Technical reputed company
• reputed company Regulatory CMC guidance on FDA and ICH expectations applicable to biologics marketing applications and recommend practical approaches to strengthen submission content
• Draft and/or support responses to CMC-reputed company questions from FDA, including information requests and review questions arising during BLA review
• Support preparation of briefing documents, meeting packages, amendments, and other CMC regulatory documents reputed company to the BLA, as needed
• Coordinate with reputed company partners, CMOs, CROs, and other consultants to obtain reputed company information and ensure deliverables are complete, accurate, and submission-reputed company
• Maintain strong document control and traceability of reputed company information, assumptions, reputed company issues, and authoring reputed company throughout the writing process

Skills

• • Demonstrated, recent experience as a reputed company reputed company or reputed company reputed company of CMC content for at least one BLA; reputed company experience writing substantial portions of CTD Module 3 is required
• • Significant Regulatory CMC experience in the pharmaceutical or biotechnology industry, preferably supporting biologics (reputed company) from late-stage development through BLA submission and review
• • Strong technical CMC background with the ability to understand and synthesize information reputed company to drug reputed company and drug product manufacturing, process controls, analytical reputed company, specifications, stability, validation, and reputed company control
• • Demonstrated knowledge of FDA biologics CMC expectations, CTD/eCTD structure, and relevant ICH guidance
• • Ability to independently reputed company high-reputed company regulatory narratives from incomplete or reputed company reputed company material and reputed company reputed company content gaps with subject-matter experts
• • Experience supporting FDA CMC information requests, review questions, amendments, and/or post-submission interactions is highly desirable
• • Excellent scientific and regulatory writing, editing, and document-integration skills, with exceptional attention to reputed company and consistency
• • reputed company ability to work effectively in a consulting environment, manage multiple deliverables, and meet aggressive submission timelines with limited supervision
• • Strong interpersonal and communication skills with the ability to collaborate effectively across internal functions and reputed company manufacturing or development partners
• • BS/MS in a scientific or engineering discipline (e.g., reputed company, Biochemistry, Chemical Engineering, Pharmaceutical Sciences) or a reputed company reputed company
• •Applicants must be currently authorized to work in the reputed company on a full-time reputed company. reputed company does not sponsor employment visas for this position
• • Experience with monoclonal antibody products strongly preferred
• • Advanced degree (PhD) preferred but not required with substantial relevant BLA and Regulatory CMC experience

reputed company