Global Regulatory CMC Lead for Biologics & ADC Programs

Excelya Group; Saclay; On-site; EUR 90,000 - 130,000; Full time

Job summary

Excelya Group is seeking a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate (ADC) biologics program. You will drive regulatory strategy, lead Module 3 CMC content, and coordinate with global health authorities to support MAAs, BLAs, and lifecycle management.

The role requires expertise in ICH, FDA, EMA regulations, and a proven ability to operate in a global matrix with cross-functional teams across development and

Qualifications

• Master’s degree or equivalent in a scientific discipline as listed.
• Solid experience leading regulatory CMC activities for biologics.
• Proven track record in MAA/BLA regulatory submissions and lifecycle management.
• Deep understanding of ICH, FDA and EMA requirements for Module 3.

Responsibilities

• Lead global Regulatory CMC strategy for biologics and ADC programs.
• Provide strategic leadership for BLA/MAA preparation, submission, and lifecycle management.
• Ensure alignment of CMC regs with development and commercial objectives.
• Anticipate regulatory risks and develop mitigation plans.
• Oversee Module 3 CMC content for global submissions.
• Coordinate interactions with health authorities (FDA, EMA).
• Drive cross-functional collaboration in a global matrix environment.
• Maintain expertise in international regulatory requirements for successful registrations.

Skills

Regulatory CMC leadership

Module 3 submissions

Global regulatory strategy

FDA/EMA knowledge

Cross-functional leadership

Regulatory submissions

Education

Master’s degree in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or related

Job description

Excelya Group is seeking a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate (ADC) biologics program. You will drive regulatory strategy, lead Module 3 CMC content, and coordinate with global health authorities to support MAAs, BLAs, and lifecycle management.

The role requires expertise in ICH, FDA, EMA regulations, and a proven ability to operate in a global matrix with cross-functional teams across development and