Associate Director, Regulatory CMC

Celldex Therapeutics • Hampton, NJ

84d • $181,043 - $190,827

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Base salary range of $181,043 to $190,827.
• Annual discretionary bonus.
• Long term incentive.
• 401(K) plan with employer contribution.
• Health care and other insurance benefits (for employee and family).
• Paid holidays, vacation, and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Ambulatory Health Care Services
• Number of Employees: 101-250 employees