Executive Director, Regulatory CMC – Global Strategy Lead

Rhythm Pharmaceuticals, Inc; Boston (MA); Hybride; USD 230 000 - 330 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

Rhythm Pharmaceuticals, Inc., a Boston-based global biopharmaceutical company, seeks an Executive Director, Regulatory CMC to lead the regulatory CMC strategy from development through post-approval.

You will partner with Technical Operations, Quality and Regulatory teams to deliver science-based documentation and guide risk-based decisions in a highly matrixed environment. This role emphasizes leadership, policy influence, and advancing Rhythm’s portfolio on a global scale.

Qualifications

• Bachelor of Science in chemical, biological or mechanical science; advanced degree preferred.
• 20+ years biopharmaceutical experience with 15+ years in regulatory CMC across modalities.
• 10+ years leading global Regulatory CMC teams and cross-functional groups.
• Experience as researcher/manufacturer/quality scientist in biotech/pharma; device exp a plus.
• Demonstrated executive communication and cross-functional influence.

Responsabilités

• Lead the Regulatory CMC function with strategic oversight across the portfolio.
• Represent Regulatory CMC in governance forums; assess risk and influence decisions.
• Translate corporate and patient priorities into Regulatory CMC priorities.
• Build and sustain networks with internal and external stakeholders.
• Set forward-looking vision including automation and AI adoption.

Connaissances

Regulatory leadership

Strategic planning

Executive communication

Team development

Stakeholder influence

Formation

Bachelor of Science in chemical/biological/mechanical science

Advanced degree preferred (PhD, MS, PharmD or MBA)

Description du poste

Rhythm Pharmaceuticals, Inc., a Boston-based global biopharmaceutical company, seeks an Executive Director, Regulatory CMC to lead the regulatory CMC strategy from development through post-approval.

You will partner with Technical Operations, Quality and Regulatory teams to deliver science-based documentation and guide risk-based decisions in a highly matrixed environment. This role emphasizes leadership, policy influence, and advancing Rhythm’s portfolio on a global scale.