Hiring: Associate Director, Regulatory Affairs CMC Company: Anagram Therapeutics, Inc. Location: Natick, MA Job Posted Time: 2026-09-11 11:01:39 About the job Experience: •8+ years of experience with 5+ years of experience in Regulatory Affairs CMC within the biotech or pharmaceutical industry, along with broad-based CMC technical and product experience Required Skills: •The Associate Director, Regulatory Affairs CMC will be responsible for leading regulatory CMC activities for Anagram’s portfolio of products, through all stages. •Assist with developing Regulatory-CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. •Prepare CMC regulatory documents in support of Investigational New Drug Applications/Amendments (INDs), Biologics License Applications (BLAs), Investigational Medicinal Product Dossiers (IMPDs), and Clinical Trial Applications (CTAs). •Regulatory Affairs CMC representative on project teams; provide guidance and communicate regulatory risks and/or mitigations. •Support development of regulatory processes and procedures to support CMC components of regulatory submissions (ie. assessment of manufacturing change controls) •Review CMC source documentation in support of dossiers. •Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines. •Support regulatory inspections and audits Qualifications: •Bachelor's degree in a scientific or related field; advanced degree preferred. •A minimum of 8+ years of experience with 5+ years of experience in Regulatory Affairs CMC within the biotech or pharmaceutical industry, along with broad-based CMC technical and product experience •Expertise in Regulatory CMC requirements throughout the product lifecycle •Strong knowledge of GMP and FDA and ICH regulations. •Demonstrated success with leading Module 3 through finalization •Strong leadership and team management skills. •Outstanding communication and interpersonal abilities. •Demonstrated capacity to thrive in a fast-paced, dynamic environment. •Fast-paced environment – Thriving in an environment of change and continuous improvement is a core competency for all members of our team. •Dynamic roles - We are a small and tight-knit team enthusiastically tackling difficult problems. All team members are expected to contribute to company protocols, provide feedback and to generally think critically about our processes. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!