Director, Regulatory Affairs, CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee all operational and lifecycle management elements related to Regulatory CMC submissions (such as INDs, IMPDs, BLAs, MAAs, variations, and amendments) that support cell therapy development initiatives.

• Formulate and implement global regulatory CMC strategies that are in line with program objectives, regulatory mandates, and the overarching business strategy.

• Act as the Regulatory CMC lead for cross-functional program teams, offering strategic regulatory counsel for cell therapy development and lifecycle oversight.

• Draft, review, and coordinate Module 3 (M3) content, ensuring consistency, quality, and alignment across global regulatory submissions (including US, EU, and other international health authorities).

• Assess the regulatory implications of CMC changes through formal change control protocols and establish and implement suitable filing strategies.

• Proactively identify CMC regulatory challenges, foresee Health Authority inquiries, and devise mitigation and contingency plans to ensure favorable outcomes.

• Lead or support engagements with health authorities by preparing briefing documents, technical justifications, responses to information requests, and regulatory meeting assistance.

• Work collaboratively across functions to ensure CMC deliverables fulfill regulatory requirements, quality benchmarks, and program timelines.

• Promote continuous improvement and best practice sharing for Regulatory CMC processes within a rapidly evolving and dynamic environment.

⛳️ Requirements

• Bachelor’s degree in a scientific discipline (such as Chemistry, Biochemistry, Biology, Chemical Engineering, or a related field).

• More than 8 years of experience in Regulatory CMC and/or drug development, including direct experience with FDA-regulated cell therapy products.

• Knowledge of GMP principles and documentation standards.

• Excellent attention to detail, strong organizational capabilities, and the ability to manage multiple priorities.

• Strong communication skills and the ability to collaborate effectively across functions.

• Capability to excel in a fast-paced, mission-driven small company atmosphere and adapt to changing priorities.

🏝️ Benefits

• Occasional travel required.