Director, Regulatory CMC

Job not on LinkedIn

🔥 21 hours ago

🏄 California, New York, +1 more states – Remote

🏄 California – Remote 🗽 New York – Remote 🍂 Massachusetts – Remote

💵 $235k - $270k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Immuneering Corporation

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🎖️ Defense

🔥 Funding within the last year

💰 $200M Post-IPO Equity - Immuneering on 2025-09

Healthcare • Consulting • Defense

Immuneering Corporation is a clinical-stage biotechnology company developing a novel class of oncology therapies called Deep Cyclic Inhibitors, which use rhythmic dosing to outpace cancer adaptation, improve tolerability, and extend patient survival and quality of life. The company advances a pipeline through clinical trials, collaborates with partners, and emphasizes scientific research and publications to transform cancer treatment while reducing side effects of traditional continuous-inhibition therapies.

📋 Description

• Develop and lead global CMC regulatory strategies for investigational and commercial products • Prepare, review, and submit CMC sections of INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to the FDA, EMA, and other regulatory authorities • Provide regulatory guidance on manufacturing changes, process development, and technology transfers • Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends • Represent Regulatory CMC in cross-functional teams and meetings • Lead interactions and communications with regulatory agencies regarding CMC topics • Use influence and project management skills to foster alignment with organizational goals • Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical, and other internal departments • Partner with CROs and consultants to ensure regulatory compliance and readiness

🎯 Requirements

• Bachelor's degree in Chemistry, Pharmacy, Life Sciences, or a related field required • Minimum of 10+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry • Experience with small molecule development in oncology • Proven track record of successful CMC submissions and approvals in the US and internationally • In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC • Strong leadership, communication, and project management skills • Ability to work collaboratively within the company's stated values • Ability to work effectively in a collaborative, fast-paced environment

🏖️ Benefits

• Competitive compensation • Equity participation • Exceptional benefits • Fully remote work environment • Flexible, results-oriented culture