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Job description
Regulatory Affairs CMC, Manager/Senior Manager
Currently partnering with a public Biotech who are currently expanding and seeking an experienced Regulatory CMC Manager to support the global development and registration of biologic products across all stages of the product lifecycle. This individual will play a key role in shaping and implementing CMC regulatory strategies, to help with commercial readiness as they prepare for a BLA submission.
Key Responsibilities
Lead the preparation, coordination, and submission of CMC documentation in support of global regulatory filings, including INDs/CTAs, BLAs/MAAs, amendments, and post-approval variations.
Draft, review, and compile high-quality CMC sections and responses to regulatory authority queries related to chemistry, manufacturing, and controls.
Partner closely with Process Development, Quality, and Technical Operations to ensure compliance with evolving regulatory requirements across all stages of clinical development and commercialization.
Support strategic planning of regulatory submissions and timelines, coordinating with internal teams and external CDMOs/CROs to ensure efficient delivery of high-quality data packages.
Provide regulatory insight and risk assessments related to change controls, deviations, inspections, and GMP investigations, ensuring appropriate documentation and communication of CMC impacts.
Serve as a regulatory CMC representative on cross-functional project teams, offering clear guidance on global submission strategy and content expectations.
Contribute to the preparation and execution of regulatory agency interactions, including meeting briefing packages and response documents.
Qualifications
Degree in a relevant field plus 4+ years of experience in Regulatory Affairs CMC.
Solid understanding of biologics CMC development, manufacturing, and regulatory principles across multiple phases of development.
Experience in Phase 2/Phase 3 preferred.
Experience authoring and compiling CMC modules (e.g., 3.2.S and 3.2.P) for electronic submissions in compliance with FDA, EMA, Health Canada, and ICH requirements.
Proven ability to collaborate effectively with cross-functional and cross-regional teams to achieve aligned regulatory objectives.
Strong organizational skills with the ability to prioritize multiple projects in a fast-paced environment.
Prior experience supporting combination products or drug-device programs is an advantage.
Apply today to learn more or reach out directly to
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.