Senior Regulatory CMC Director

Rhythm Pharmaceuticals, Inc; Boston (MA); Hybrid; USD 182,000 - 275,000; Full time

Benefits offered by this job

Discretionary bonus

Benefits package

Restricted stock units (RSUs)

Hybrid work model

Job summary

Rhythm Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality, compliant CMC deliverables for assigned programs.

This individual contributor role collaborates with Global Regulatory Affairs, Technical Operations, and Quality to ensure timely, complete submissions and alignment with global requirements. The role is based in Boston with a hybrid-work model and may require some travel.

Qualifications

• Minimum a B.S. in a scientific or life sciences discipline with 10+ years in Regulatory CMC, manufacturing, analytics, quality, or related pharma environments.
• Experience supporting regulatory programs for rare diseases or high unmet medical need is preferred.
• Experience preparing CMC docs for clinical, marketing, post-approval submissions, and health authority responses.
• Experience with peptides and injectable dosage forms and/or injection drug delivery devices is required.
• Strong ability to manage multiple deliverables and meet aggressive timelines.
• Knowledge of global CMC regulatory requirements across multiple ICH regions.

Responsibilities

• Serve as regulatory CMC representative on cross-functional teams and execute deliverables aligned with strategy.
• Author, compile, review, and finalize high-quality CMC docs and submissions (core dossiers, INDs, IMPDs, MAAs, BLAs, variations, annual reports).
• Coordinate timely regulatory filings and submission activities across regions and timelines.
• Prepare regulatory CMC meeting requests, briefing materials, and supporting documents for health authorities.
• Assess CMC change controls for regulatory impact and filing requirements.
• Track commitments, questions, and actions; coordinate cross-functional responses within deadlines.
• Maintain knowledge of relevant CMC regs, guidance, and regional expectations; communicate impact to stakeholders.
• Contribute to continuous improvement of regulatory processes, templates, SOPs, and systems.

Skills

Regulatory CMC

Manufacturing

Analytical development

Quality

Cross-functional collaboration

Project management

Global regulatory knowledge

Communication

Education

B.S. in scientific or life sciences

Job description

Rhythm Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality, compliant CMC deliverables for assigned programs.

This individual contributor role collaborates with Global Regulatory Affairs, Technical Operations, and Quality to ensure timely, complete submissions and alignment with global requirements. The role is based in Boston with a hybrid-work model and may require some travel.