Global Regulatory CMC Executive Director

Rhythm Pharmaceuticals Inc.

Boston (MA)

Hybrid

USD 230,000 - 330,000

Full time

21 hours ago
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Benefits offered by this job

Hybrid work model
Bonus potential
Competitive benefits

Job summary

Rhythm Pharmaceuticals Inc. seeks an Executive Director, Regulatory CMC to lead a global Regulatory CMC team, shaping portfolio strategy from development through post-approval.

You will partner across Technical Operations, Quality and Regulatory to deliver science-based CMC documentation and drive risk-based decision-making. You will guide enterprise-level strategies, build talent, and evolve the function with rhythms of Rhythm’s portfolio while maintaining focus on patient access and regulatory

Qualifications

  • Bachelor of Science in chemical, biological or mechanical science required; advanced degree preferred (PhD/MS/PharmD/MBA).
  • Target of 20+ years in biopharmaceutical/pharmaceutical industry with 15+ years in regulatory CMC across modalities.
  • 10+ years managerial/global Regulatory CMC leadership experience expected.
  • Experience as a research, manufacturing or quality scientist in biotech/pharma beneficial for regulatory CMC.

Responsibilities

  • Lead Regulatory CMC function with strategic oversight across portfolio, including strategy, risk assessment, and outcomes.
  • Represent Regulatory CMC in governance forums; influence cross-functional portfolio decisions.
  • Translate corporate and patient priorities into Regulatory CMC priorities and build business acumen within the team.
  • Develop and lead a high-performing Regulatory CMC team with coaching and talent development.
  • Adopt automation, AI, and new ways of working to improve efficiency and strategic contribution.
  • Oversee resource planning, budget management, and development of processes and standards.

Skills

Regulatory CMC leadership
Global regulatory submissions
Cross-functional leadership
Executive communication
Risk assessment
FDA experience
English fluency

Education

Bachelor of Science in chemical/biological/mechanical science
Advanced degree (PhD, MS, PharmD or MBA) preferred

Job description

Rhythm Pharmaceuticals Inc. seeks an Executive Director, Regulatory CMC to lead a global Regulatory CMC team, shaping portfolio strategy from development through post-approval.

You will partner across Technical Operations, Quality and Regulatory to deliver science-based CMC documentation and drive risk-based decision-making. You will guide enterprise-level strategies, build talent, and evolve the function with rhythms of Rhythm’s portfolio while maintaining focus on patient access and regulatory

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