Associate Director, Regulatory Affairs – CMC

BlueRock Therapeutics

Associate Director guiding CMC regulatory strategy for BlueRock’s engineered cell therapies. Leading global submissions, Health Authority interactions, and regulatory plans for clinical-stage medicines.

Posted 8/17/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $222,435 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a focus on CMC for cell and gene therapy products, including extensive experience in preparing regulatory submissions and interfacing with health authorities. Proven ability to lead complex regulatory strategies and manage multiple projects effectively.

Highest-signal resume keywords

Regulatory Affairs ExpertiseCMC Submission PreparationHealth Authority InteractionGlobal Regulatory Strategy DevelopmentBiologics and Cell Therapy Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsCMCRegulatory Submission PreparationECTD FormatBiologicalsTherapeutic ProteinsCell and Gene TherapyRegulatory Strategy DevelopmentChange Control AssessmentQuality Dossier Generation

Soft Skills

Excellent Communication SkillsAttention to DetailProject ManagementCollaboration

Tools & Technologies

Electronic Submission SystemsWordExcelPowerPoint

Industry Keywords

Health AuthorityIND/CTANDA/BLA/MAAICH GuidelinesGlobal RegulationsPharmaceuticalBiotechnology

About the role

Key responsibilities & impact

Provide regulatory leadership and guidance to CMC teams developing cell and gene therapy products
Oversee and generate quality dossiers for Health Authority meetings, clinical trial applications, and market applications in the U.S. and international territories
Represent Regulatory CMC on and/or lead matrix teams for cell and gene therapy pipeline products
Provide strategic guidance related to regulatory requirements and expectations for clinical trial and marketing applications
Manage and prioritize multiple complex projects
Drive Health Agency interaction workflows, including briefing documents and responses to questions
Interface with Health Authorities on CMC submissions and CMC-related issues
Identify, communicate, and propose resolutions to routine and complex strategic issues
Interpret global regulations and guidance and identify regulatory opportunities and risks
Review and provide regulatory assessments on change controls
Prepare and manage CMC submissions for global markets, including creation and maintenance of strategy documents
Manage relationships with diverse technical and project teams
Utilize electronic systems for dossier creation and tracking
Support departmental initiatives, special projects, budgeting, and authoring departmental documents

Requirements

What you’ll need

Bachelor’s degree or equivalent in Regulatory Science or related field
6 years of experience in Regulatory Affairs, CMC
Experience in a global pharmaceutical and/or biotechnology company
Expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products
Direct experience interfacing with regulatory authorities
Extensive experience preparing quality sections of regulatory filings, including Health Authority briefing documents, IND/CTA, and NDA/BLA/MAA
Ability to lead regulatory CMC discussions with global regulatory authorities
Experience preparing electronic submissions following eCTD format
Knowledge and understanding of U.S., international regulations, and ICH guidelines related to biologics and cell therapy development
Experience leading the development and implementation of complex regulatory strategies, with significant regulatory accomplishments
Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions
Ability to understand regulatory impacts of manufacturing and quality control changes
Ability to collaborate effectively with process development, manufacturing, Quality Assurance, Quality Control, non-clinical development, clinical development, and clinical operations experts
Excellent written and communication skills with attention to detail
Highly computer literate, including Word, Excel, and PowerPoint, and formatting documents for regulatory submission

Benefits

Comp & perks

Fully remote work / telecommuting permitted
25% travel within US/Canada, with some additional limited EU travel possible
Equal opportunity workplace
Disability-related and other legally protected-ground accommodation during recruitment