Remote Director, Regulatory CMC - Global Submissions Leader

Immuneering Corporation; Cambridge (MA); On-site; USD 235,000 - 270,000; Full time

Benefits offered by this job

Fully remote

Equity participation

Excellent benefits

Job summary

Immuneering Corporation in Cambridge, MA seeks a Director of Regulatory CMC to lead global CMC regulatory strategies for investigational and commercial products. You will prepare and submit CMC sections for INDs, NDAs, and other filings, interfacing with FDA/EMA and cross-functional teams.

The ideal candidate has 10+ years in CMC regulatory affairs, deep FDA/EMA knowledge, and strong leadership and project-management skills.

Qualifications

• Minimum 10+ years in CMC regulatory affairs within biopharma/pharmaceuticals, oncology focus preferred.
• Proven track record of successful CMC submissions and approvals in US and internationally.
• Deep knowledge of FDA, EMA, and ICH guidelines and processes related to CMC.
• Strong leadership, communication, and project management skills.

Responsibilities

• Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals.
• Prepare, review, and submit CMC sections of regulatory documents (INDs, IMPDs, NDAs, BLAs, ANDAs, supplements).
• Provide regulatory guidance on CMC matters to project teams, including manufacturing changes and tech transfers.
• Monitor emerging CMC regulatory requirements and industry trends to address impacts.
• Lead interactions with regulatory agencies on CMC topics (pre-IND, end-of-phase, pre-submission).
• Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical and CROs to ensure regulatory readiness.

Skills

Leadership

Regulatory Affairs

CMC

Regulatory Strategy

Project Management

Education

Bachelor's in Chemistry/Pharma/Life Sciences

PhD/PharmD/MS preferred

Job description

Immuneering Corporation in Cambridge, MA seeks a Director of Regulatory CMC to lead global CMC regulatory strategies for investigational and commercial products. You will prepare and submit CMC sections for INDs, NDAs, and other filings, interfacing with FDA/EMA and cross-functional teams.

The ideal candidate has 10+ years in CMC regulatory affairs, deep FDA/EMA knowledge, and strong leadership and project-management skills.