Regulatory CMC Lead: Strategy & Submissions

Anagram Therapeutics, Inc.; Natick (MA); On-site; USD 170,000 - 210,000; Full time

Job summary

Anagram Therapeutics, Inc. in Natick, MA is seeking an Associate Director to lead regulatory CMC activities across a broad portfolio for clinical and commercial programs.

You will plan submission strategies, coordinate cross-functional teams, and ensure submissions meet health authority requirements. The role requires deep experience with regulatory CMC throughout the product lifecycle, INDs/NDA/BLA experience, and strong leadership.

Qualifications

• Bachelor's degree in a scientific or related field.
• 8+ years of experience in regulatory CMC within biotech or pharmaceutical industry.
• Expertise in Regulatory CMC requirements throughout the product lifecycle.
• Strong knowledge of GMP, FDA and ICH regulations.
• Proven leadership and ability to drive cross-functional teams.

Responsibilities

• Lead regulatory CMC activities for Anagram’s portfolio through all stages.
• Assist with developing Regulatory-CMC strategies and collaborating with key stakeholders to execute strategies.
• Prepare CMC regulatory documents for INDs, BLAs, IMPDs, and 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 submissions (e.g., manufacturing change controls).
• Review CMC source documentation in support of dossiers.
• Review documents for submission-readiness and ensure conformity with health authority guidelines.
• Ensure high-quality and on-time submissions for INDs, IMPDs, CTAs, and BLAs; coordinate milestones.
• Support regulatory inspections and audits.
• Navigate regulatory landscape and stay up-to-date with evolving requirements.

Skills

Regulatory CMC leadership

Cross-functional leadership

IND/NDA/BLAs

GMP knowledge

FDA/ICH regulations

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

Anagram Therapeutics, Inc. in Natick, MA is seeking an Associate Director to lead regulatory CMC activities across a broad portfolio for clinical and commercial programs.

You will plan submission strategies, coordinate cross-functional teams, and ensure submissions meet health authority requirements. The role requires deep experience with regulatory CMC throughout the product lifecycle, INDs/NDA/BLA experience, and strong leadership.