Associate Director, Regulatory CMC

Role Summary

We are seeking an experienced and strategic Associate Director of Regulatory CMC to lead regulatory Chemistry, Manufacturing, and Controls (CMC) activities for combination products (drug-device). The ideal candidate will bring deep expertise in BLA submissions, Module 3 authoring and review, and the regulatory landscape for combination product development and manufacturing.

This role reports into the Head of Regulatory CMC and will play a key part in shaping regulatory strategies, preparing high-quality submissions, and supporting product approvals across a diverse combination product portfolio.

Responsibilities

• Develop and execute global Regulatory CMC strategies for drug-device combination products throughout development and commercialization.
• Author, review, and finalize Module 3 (Quality) sections for regulatory submissions including INDs, BLAs, and global dossiers.
• Serve as Regulatory CMC lead on cross-functional teams to ensure alignment across all CMC aspects.
• Drive preparation for and participation in regulatory agency meetings, addressing CMC-related queries and managing agency interactions effectively.

Qualifications

• Minimum 8+ years of Regulatory CMC experience, with direct experience authoring and reviewing Module 3 content for INDs/BLAs.
• 3+ years of experience with combination products (drug-device) and deep understanding of applicable regulatory guidance.
• Strong track record in leading successful BLA submissions.
• Exceptional writing, analytical, and project management skills.

Preferred Qualifications

• Familiarity with drug delivery devices (e.g., prefilled syringes, autoinjectors).
• Experience with eCTD publishing platforms and document management systems.
• Global regulatory experience, especially EMA, Health Canada, PMDA, or other major markets.