Director, Regulatory CMC – Oncology (Remote)

Regulatory Jobs; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Fully remote work environment

Equity participation

Competitive benefits

Job summary

Immuneering Corporation in a fully remote setting seeks a Director/Senior Director, Regulatory CMC to lead global CMC regulatory strategies across our clinical portfolio.

You will prepare and submit CMC sections for INDs, NDAs, BLAs, and other filings to the FDA, EMA and other authorities, and advise on process changes and tech transfers.

The role demands strong leadership, cross-functional collaboration, and a data-driven, compliant approach in a fast-moving biopharma environment.

Qualifications

• 10+ years of CMC regulatory affairs experience in pharma/biotech
• Proven track record of US and international regulatory submissions and approvals
• In-depth knowledge of FDA, EMA, and ICH guidelines related to CMC
• Strong leadership, communication, and project management skills

Responsibilities

• Develop and lead global CMC regulatory strategies for investigational and commercial products
• Prepare, review, and submit CMC sections of regulatory documents including INDs, NDAs, BLAs, ANDAs, and supplements
• Provide regulatory guidance on CMC matters to project teams (manufacturing changes, process development, technology transfers)
• Monitor current and emerging CMC regulatory requirements and trends
• Lead interactions with regulatory agencies for pre-IND, end-of-phase, and pre-submission meetings
• Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical, and external partners to ensure regulatory readiness

Skills

CMC regulatory affairs

Regulatory strategy

Leadership

Cross-functional collaboration

FDA/EMA/ICH guidelines

Education

Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or related field

Advanced degree (PhD, PharmD, MS) preferred

Job description

Immuneering Corporation in a fully remote setting seeks a Director/Senior Director, Regulatory CMC to lead global CMC regulatory strategies across our clinical portfolio.

You will prepare and submit CMC sections for INDs, NDAs, BLAs, and other filings to the FDA, EMA and other authorities, and advise on process changes and tech transfers.

The role demands strong leadership, cross-functional collaboration, and a data-driven, compliant approach in a fast-moving biopharma environment.