Director, Regulatory CMC — Global Submissions

rhythmpharmaceuticals; Boston (MA); Hybrid; USD 182,000 - 275,000; Full time

Job summary

Rhythm Pharmaceuticals in Boston, MA is seeking an experienced Regulatory CMC professional to lead high-quality, compliant deliverables for assigned programs, collaborating with Global Regulatory Affairs, Technical Operations, and Quality.

You will author and review core dossiers, INDs, MAAs, and variations; manage filings and health authority interactions; and ensure timely execution while maintaining knowledge of global CMC requirements.

Qualifications

• Minimum 10 years of Regulatory CMC experience in pharmaceutical environments.
• Experience supporting regulatory programs for rare diseases with high unmet medical need.
• Experience preparing CMC documentation for clinical trials, marketing applications, post-approval submissions, and health authority responses.
• Experience with peptides and injectable dosage forms and/or injection drug delivery devices.
• Strong execution skills with ability to manage multiple deliverables and deadlines.
• Working knowledge of global CMC regulatory requirements across ICH regions.
• Ability to work independently within strategic direction and escalate risks appropriately.
• Strong organizational, planning, communication, and collaboration skills across Global Regulatory Affairs, Technical Operations, and Quality.

Responsibilities

• Serve as the regulatory CMC representative on cross-functional teams and execute deliverables.
• Author, compile, review, and finalize high-quality CMC documents and submissions (core dossiers, INDs, IMPDs, MAAs, BLAs, variations, annual reports).
• Coordinate and support timely execution of regulatory filings and submission activities.
• Prepare regulatory CMC meeting requests, briefing materials, and supporting documentation.
• Assess CMC change controls for regulatory impact and regional requirements.
• Track regulatory commitments, health authority questions, and submission-related actions with cross-functional responses.
• Maintain knowledge of relevant CMC regulations and communicate executional impact to stakeholders.
• Contribute to continuous improvement of regulatory processes, templates, SOPs, and systems.

Skills

Regulatory CMC

Peptides & injectables

CMC documentation

Cross-functional collaboration

Global regulatory knowledge

Independent work

Project management

Education

B.S. in life sciences

Job description

Rhythm Pharmaceuticals in Boston, MA is seeking an experienced Regulatory CMC professional to lead high-quality, compliant deliverables for assigned programs, collaborating with Global Regulatory Affairs, Technical Operations, and Quality.

You will author and review core dossiers, INDs, MAAs, and variations; manage filings and health authority interactions; and ensure timely execution while maintaining knowledge of global CMC requirements.