Senior Regulatory Affairs CMC Lead — IND/BLAs & Submissions

Anagram Therapeutics, Inc.; Natick (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Anagram Therapeutics, Inc. is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio through all development stages in a fast-paced biotech environment.

You will develop regulatory-CMC strategies, coordinate INDs/BLAs, prepare compilations, review dossiers for submission readiness, and guide cross-functional teams to ensure compliance with GMP, FDA and ICH requirements.

Qualifications

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• A minimum of 8+ years of experience with 5+ years in Regulatory Affairs CMC within biotech/pharmaceuticals.
• Expertise in Regulatory CMC requirements throughout the product lifecycle.
• Experience with INDs and NDA/BLAs.
• Strong knowledge of GMP and FDA and ICH regulations.

Responsibilities

• Lead regulatory CMC activities for Anagram’s portfolio through all stages.
• Develop Regulatory-CMC strategies and collaborate with stakeholders to execute aligned with business priorities.
• Prepare CMC regulatory documents for INDs, BLAs, IMPDs, and CTAs.
• Serve as Regulatory Affairs CMC representative on project teams; guide and communicate regulatory risks and mitigations.
• Support development of regulatory processes for CMC dossiers and validate change controls.
• Review CMC source documentation and submissions for readiness and compliance.
• Ensure high-quality, on-time submissions aligned with health authority requirements.
• Support regulatory inspections and audits; stay updated on evolving requirements.

Skills

Regulatory CMC leadership

INDs/NDAs/BLAs

GMP FDA ICH knowledge

Cross-functional collaboration

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

Anagram Therapeutics, Inc. is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio through all development stages in a fast-paced biotech environment.

You will develop regulatory-CMC strategies, coordinate INDs/BLAs, prepare compilations, review dossiers for submission readiness, and guide cross-functional teams to ensure compliance with GMP, FDA and ICH requirements.