Regulatory CMC Director — Lead Global Submissions (Hybrid)

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

Benefits offered by this job

Discretionary annual bonus

Restricted stock units

Job summary

Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables.

You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical Operations, and Quality, and ensure timely, compliant submissions across development, commercialization, and lifecycle events. The role requires extensive experience with peptides/injectables, and a proven ability to manage

Qualifications

• A minimum of a B.S. degree in a scientific or life sciences discipline with a minimum of 10 years experience in Regulatory CMC, manufacturing, analytical development, quality, or related pharmaceutical development environments.
• Demonstrated experience supporting regulatory programs for products intended to treat rare diseases and/or conditions with high unmet medical need is preferred.
• Experience preparing CMC documentation to support clinical trial applications, marketing applications, post-approval submissions, and health authority responses.
• Experience with peptides and injectable dosage forms and/or injection drug delivery devices is required.
• Strong execution skills with demonstrated ability to manage multiple deliverables, coordinate cross-functional input, and deliver high-quality work within aggressive timelines.
• Working knowledge of global CMC regulatory requirements, guidelines, and expectations across development, registration, and lifecycle management in multiple ICH regions.

Responsibilities

• Serve as the regulatory CMC representative on cross-functional teams for assigned programs and execute deliverables in alignment with strategies established by Global Regulatory Affairs and Technical Operations.
• Author, compile, review, and finalize high-quality CMC regulatory documents and submissions, including core dossiers, INDs, IMPDs, MAAs, BLAs, variations, and annual reports, in collaboration with internal and external stakeholders.
• Coordinate and support the timely execution of regulatory filings and submission activities in compliance with applicable global regulatory requirements, commitments, and internal timelines.
• Prepare regulatory CMC meeting requests, briefing materials, and supporting documentation to enable effective health authority interactions and internal governance reviews.
• Assess CMC change controls to determine regulatory impact, identify filing requirements across regions, evaluate supporting documentation, and ensure risks or gaps are escalated appropriately.
• Track regulatory commitments, health authority questions, and submission-related action items, and coordinate cross-functional responses within agreed timelines.
• Maintain current knowledge of relevant CMC regulations, guidance, and regional expectations, and communicate executional impact to internal stakeholders.
• Contribute to continuous improvement of regulatory processes, templates, SOPs, and systems that support efficient and compliant document development and submission execution.

Skills

Regulatory CMC

CMC documentation

Health authority interactions

Peptides and injectables

Education

B.S. degree in life sciences

Job description

Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables.

You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical Operations, and Quality, and ensure timely, compliant submissions across development, commercialization, and lifecycle events. The role requires extensive experience with peptides/injectables, and a proven ability to manage