Associate Director, Regulatory Affairs CMC — Strategy Lead

Anagram Therapeutics, Inc.; Natick (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Anagram Therapeutics, Inc. in Natick, MA is seeking an experienced Associate Director to lead Regulatory Affairs CMC across development and lifecycle stages.

You will plan submission strategies, prepare CMC documents for INDs/NDAs/BLAs, and collaborate with cross-functional teams to ensure compliant, timely filings while navigating evolving regulatory requirements.

Lead regulatory strategy, guide teams through Module 3, and drive inspections readiness in a fast-paced biotech setting.

Qualifications

• 8+ years of regulatory experience with 5+ years in Regulatory Affairs CMC.
• Expertise across INDs, NDAs/BLAs and post‑approval submissions.
• Strong knowledge of GMP, FDA and ICH regulations.
• Proven leadership and cross‑functional collaboration skills.

Responsibilities

• Lead regulatory CMC activities for Anagram’s product portfolio across all stages.
• Develop Regulatory-CMC strategies with key stakeholders.
• Prepare CMC documents for INDs, BLAs, IMPDs, and CTAs.
• Represent CMC on project teams and communicate regulatory risks.
• Support development of CMC submission processes and change controls.
• Review CMC source docs for dossiers and submission readiness.
• Ensure high-quality, on-time submissions aligned with health authority requirements.
• Support regulatory inspections and audits.

Skills

Regulatory CMC

Leadership

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

Anagram Therapeutics, Inc. in Natick, MA is seeking an experienced Associate Director to lead Regulatory Affairs CMC across development and lifecycle stages.

You will plan submission strategies, prepare CMC documents for INDs/NDAs/BLAs, and collaborate with cross-functional teams to ensure compliant, timely filings while navigating evolving regulatory requirements.

Lead regulatory strategy, guide teams through Module 3, and drive inspections readiness in a fast-paced biotech setting.