CMC Regulatory Lead: Global Submissions & Strategy

Jobtailor; New Jersey; On-site; USD 120,000 - 190,000; Full time

Job summary

Jobtailor is seeking an experienced Regulatory CMC Leader to drive global CMC regulatory strategies and submissions for small-molecule and peptide programs. You will lead cross-functional teams, prepare NDA/MAA CTD content, and interact with health authorities to shape development milestones.

The role requires strong technical leadership, excellent written and verbal communication in multicultural settings, and a proven record delivering compliant regulatory outcomes in complex US and

Qualifications

• BS in biological science, engineering, or related field; advanced degree preferred.
• 5–10 years of pharmaceutical development experience including regulatory CMC or related fields.
• At least 7 years of experience in Regulatory CMC roles.
• Experience leading NDA/MAA CTD content preparation.
• Strong technical leadership and cross-functional influence.
• Understanding of pharmaceutical operations including manufacturing, process development, analytical, and QA.
• Excellent oral and written communication in multicultural settings.
• Ability to lead direct or matrixed teams and meet timelines.
• Proficiency in English; additional languages a plus.
• No visa sponsorship available; US or Puerto Rico resident.

Responsibilities

• Develop and implement CMC regulatory strategies for pharmaceutical products.
• Lead preparation and submission of CMC dossiers supporting global market applications.
• Serve as CMC Product Lead for new small-molecule and peptide pharmaceutical products.
• Deliver regulatory milestones throughout product development, including assessing regulatory success probability and mitigation measures.
• Lead Regulatory CMC discussions and interactions with regulatory agencies.
• Provide regulatory leadership, oversight, and strategy to matrixed Regulatory CMC teams.
• Prepare INDs/CTAs, Agency Background Packages, and Worldwide Marketing Applications, including Most of World applications.
• Provide regulatory leadership for product in-licensing and due-diligence reviews.
• Manage CMC documentation execution, including IND/CTA, original NDA/MAA, agency background packages, and responses to health-authority questions.
• Identify, communicate, and escalation potential regulatory issues to GRACS CMC management.
• Evaluate and develop team talent and prepare succession plans.
• Support approval and launch market supply of pharmaceutical products worldwide.
• Conduct all activities with a focus on compliance.

Skills

Regulatory CMC Strategy

NDA/MAA Preparation

Pharmaceutical Operations Knowledge

Technical Leadership in Regulatory CMC

Multicultural Communication Skills

Education

Bachelor's degree in biological science or related field

Job description

Jobtailor is seeking an experienced Regulatory CMC Leader to drive global CMC regulatory strategies and submissions for small-molecule and peptide programs. You will lead cross-functional teams, prepare NDA/MAA CTD content, and interact with health authorities to shape development milestones.

The role requires strong technical leadership, excellent written and verbal communication in multicultural settings, and a proven record delivering compliant regulatory outcomes in complex US and