Director, Regulatory CMC Strategy & Submissions

Anagram Therapeutics, Inc.; Natick (MA); Presencial; USD 170.000 - 250.000; Jornada completa

Descripción de la vacante

Anagram Therapeutics, Inc. is seeking a Director of Regulatory Affairs CMC to lead regulatory CMC activities across development and commercial products. The role requires building strategies, coordinating cross-functional teams and ensuring timely, compliant submissions.

You will prepare regulatory documents for INDs, BLAs, IMPDs, and CTAs, and guide risk assessments and mitigations while navigating complex regulatory landscapes. Strong leadership and communication are essential.

Formación

• Bachelor's degree in a scientific field; advanced degree preferred.
• Minimum 12+ years in regulatory affairs with 7+ years in Regulatory Affairs CMC.
• Expertise in Regulatory CMC requirements across product lifecycle including INDs/NDA/BLA.
• Strong knowledge of GMP, FDA and ICH regulations.
• Proven success leading Module 3 through finalization and regulatory submissions.

Responsabilidades

• Lead regulatory CMC activities for the product portfolio across all stages.
• Develop Regulatory-CMC strategies and collaborate with stakeholders to execute priorities.
• Prepare CMC documents for INDs, BLAs, IMPDs, and CTAs.
• Represent Regulatory CMC on project teams; communicate risks and mitigations.
• Support development of regulatory processes for CMC submissions and change controls.
• Review CMC source documentation and submission-ready materials per guidelines.
• Ensure high-quality, on-time submissions for INDs, IMPDs, CTAs, and BLAs.
• Support regulatory inspections and audits; stay updated on evolving requirements.

Conocimientos

Regulatory leadership

Cross-functional collaboration

Regulatory strategy

Leadership

Educación

Bachelor's degree

Advanced degree preferred

Descripción del empleo

Anagram Therapeutics, Inc. is seeking a Director of Regulatory Affairs CMC to lead regulatory CMC activities across development and commercial products. The role requires building strategies, coordinating cross-functional teams and ensuring timely, compliant submissions.

You will prepare regulatory documents for INDs, BLAs, IMPDs, and CTAs, and guide risk assessments and mitigations while navigating complex regulatory landscapes. Strong leadership and communication are essential.