Associate Director, Regulatory Affairs CMC

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

Responsibilities:

• 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.
• Ensures high-quality and on-time submissions, for INDs, IMPDs, CTAs, Comparability protocols and BLAs that align with company strategies and Health Authority requirements. This includes planning, writing, coordinating, and tracking the CMC dossier towards submission milestones - interacting with cross-functional departments to ensure deliverables are met according to the corporate goals.
• Support regulatory inspections and audits
• Navigate the complex regulatory landscape, staying up-to-date with evolving requirements.

Requirements:

• 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
• Experience with INDs, and NDA’s/BLAs
• 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.
• Ability to thrive in a fast-paced, dynamic environment.
• Strong problem-solving capabilities.

Working at Anagram

• 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.
• High expectations - We have big goals for the future. We expect dedication and positive collaboration from all our team to achieve them.