CMC Regulatory Affairs Executive Leader (Global)

Crescent Biopharma; Waltham (MA); On-site; USD 290,000 - 323,000; Full time

Benefits offered by this job

100% employer-paid benefits package

Flexible PTO with two company shutdown

Long-term incentive program

Professional development resources

Job summary

Crescent Biopharma is seeking a senior Regulatory Affairs CMC leader to oversee global submissions and ensure compliance across the product lifecycle. You will lead IND/MAA programs, negotiate with FDA/EMA, and guide TechOps and Quality to readiness for clinical and commercial supply.

The role requires 12+ years in CMC regulatory affairs, strong negotiation skills, and experience with biologics/ADC platforms. Leadership and strategic thinking are essential in a fast-paced environment.

Qualifications

• BS/BA Degree in a scientific discipline; advanced degree (MS/PhD) preferred.
• 12+ years in Regulatory Affairs CMC within Pharma/Biotech.
• Strong negotiation with health authorities (FDA/EMA) and submissions.
• Experience leading INDs and Marketing Applications (MAA).
• Experience with antibody-drug conjugates and biologics.
• Strong analytical, strategic thinking and problem-solving.
• Excellent communication and leadership; able to influence across levels.

Responsibilities

• Lead and/or oversee global regulatory CMC submissions through product lifecycle.
• Proactively identify regulatory risks, opportunities, and mitigation strategies with management.
• Provide strategic regulatory guidance to TechOps and Quality for global compliance.
• Serve as primary interface with global regulatory agencies for CMC negotiations & information requests.
• Provide regulatory input on product-compliance activities including change controls & investigations.
• Manage junior team members and contractors to support development activities.

Skills

Regulatory CMC

IND/CTA/MAA submissions

FDA/EMA negotiations

Leadership

Strategic thinking

Biologics/ADC experience

Communication

Team management

Education

BS/BA in scientific discipline

MS/PhD preferred

Job description

Crescent Biopharma is seeking a senior Regulatory Affairs CMC leader to oversee global submissions and ensure compliance across the product lifecycle. You will lead IND/MAA programs, negotiate with FDA/EMA, and guide TechOps and Quality to readiness for clinical and commercial supply.

The role requires 12+ years in CMC regulatory affairs, strong negotiation skills, and experience with biologics/ADC platforms. Leadership and strategic thinking are essential in a fast-paced environment.