Global Regulatory CMC Director — Oncology

Medium; Waltham (MA); Presencial; USD 290 000 - 323 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive compensation

100% employer-paid benefits

Flexible PTO

Company-wide shutdowns

Professional development

Resumo da oferta

Crescent Biopharma in Waltham, MA is seeking a Senior Regulatory Affairs CMC Lead to drive global CMC submissions and regulatory strategy across the lifecycle of our oncology programs. You will partner with TechOps, Quality, and external regulators, lead IND/MAA activities, and mentor a team while shaping risk-based approaches to compliance and lifecycle management.

This role offers competitive compensation, generous benefits, and opportunities to influence development timelines and global

Qualificações

• BS/BA in a scientific discipline; advanced degree required.
• 12 years experience in Regulatory Affairs CMC in Pharma/Biotech.
• Strong negotiation skills with health authorities (FDA, EMA) and submissions.
• Experience leading IND and Marketing Applications.
• Experience with antibody drug conjugates and biologics.
• Strong analytical, strategic thinking, and problem-solving skills.
• Excellent communication and leadership abilities; able to influence across all levels.
• Ability to thrive in a fast-paced, ambiguous environment while managing competing priorities.
• Commitment to fostering a diverse and inclusive workplace.

Responsabilidades

• Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through product lifecycle.
• Proactively identify regulatory risks, opportunities, and mitigation strategies in alignment with objectives, and communicate to management, as needed
• Provide strategic regulatory guidance to TechOps and Quality organizations to ensure global compliance and readiness for clinical and commercial supply
• Serve as the primary interface with global regulatory agencies for CMC-related negotiations, milestone meetings, and information requests.
• Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.
• Manage junior team members and contractors to support development activities

Conhecimentos

Regulatory CMC leadership

FDA/EMA negotiations

IND/Marketing Applications

Biologics/Antibody-drug conjugates

Regulatory strategy

People management

Communication skills

Formação académica

BS/BA in Scientific Discipline

Advanced degree (MS, PhD)

Descrição da oferta de emprego

Crescent Biopharma in Waltham, MA is seeking a Senior Regulatory Affairs CMC Lead to drive global CMC submissions and regulatory strategy across the lifecycle of our oncology programs. You will partner with TechOps, Quality, and external regulators, lead IND/MAA activities, and mentor a team while shaping risk-based approaches to compliance and lifecycle management.

This role offers competitive compensation, generous benefits, and opportunities to influence development timelines and global