Executive Director, Regulatory CMC Strategy (Remote/Hybrid)

Rhythm Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 230,000 - 330,000; Full time

Benefits offered by this job

Discretionary annual bonus

Restricted stock units (RSUs)

Comprehensive benefits package

Job summary

Rhythm Pharmaceuticals Inc. seeks an Executive Director, Regulatory CMC to lead an integrated regulatory CMC group, owning the portfolio strategy from development through post-approval.

Collaborate with Technical Operations, Quality, and Regulatory to deliver science-based documentation across modalities. You will guide enterprise-level regulatory CMC strategies, develop talent, and evolve the function with Rhythm's portfolio, ensuring alignment with global health authorities and industry

Qualifications

• Bachelor degree in a chemical, biological or mechanical science; advanced degree preferred.
• Minimum 20+ years in biopharmaceutical/pharmaceutical industry; 15+ years in regulatory CMC across modalities.
• Prior managerial experience leading global Regulatory CMC professionals or cross-functional teams.
• Experience as a research, manufacturing or quality scientist in biotech/pharma; device experience a plus.
• Demonstrated ability to influence cross-functional decisions and manage regulatory risk.
• Regulatory CMC expertise in at least one ICH region with leadership of major global submissions.
• Executive-level communication and influencing skills; FDA experience preferred.
• Servant leadership with track record of developing talent and accountability.
• Role models Rhythm's values and English fluency.

Responsibilities

• Lead Regulatory CMC function with strategic oversight across the portfolio.
• Represent Regulatory CMC in governance forums; influence portfolio decisions.
• Translate corporate and patient priorities into Regulatory CMC priorities.
• Build and sustain networks with internal/external stakeholders.
• Anticipate global regulatory changes and advise on portfolio impact.
• Provide senior leadership for global health authority interactions.
• Develop high-performing Regulatory CMC team and leadership capability.
• Set forward-looking vision including automation and new ways of working.
• Oversee resource planning, budget, and training for the function.
• Partner with senior leaders to evaluate portfolio priorities and risks.

Skills

Executive leadership

Strategic influence

Cross-functional collaboration

Executive communication

People development

Fluent English

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 an integrated regulatory CMC group, owning the portfolio strategy from development through post-approval.

Collaborate with Technical Operations, Quality, and Regulatory to deliver science-based documentation across modalities. You will guide enterprise-level regulatory CMC strategies, develop talent, and evolve the function with Rhythm's portfolio, ensuring alignment with global health authorities and industry