Global Regulatory CMC Lead for Biologics & ADCs

Excelya; Saclay; On-site; EUR 90,000 - 140,000; Full time

Job summary

Excelya is seeking a Senior Regulatory Consultant to deliver strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate (ADC) biologics program. The role requires steering global CMC activities for MAA/BLA submissions, with an emphasis on strategy and matrix-management leadership.

The consultant will interact with global health authorities (FDA, EMA) and guide cross-functional teams to ensure regulatory readiness and lifecycle management of biologics products.

Qualifications

• Regulatory CMC expertise in pharma/biologics.
• Proven lead on Module 3 submissions for biologics MAAs/BLA.
• Understanding of ICH, FDA, EMA regulations.

Responsibilities

• Lead global Regulatory CMC strategy for biologics and ADC programs.
• Provide leadership for global BLA/MAA preparation, submission, and lifecycle management.
• Align CMC regulatory strategies with product development and commercialization.
• Anticipate regulatory risks and implement mitigation plans.
• Oversee Module 3 CMC content for global submissions.
• Ensure quality and consistency of submission documents.
• Interact with global health authorities (FDA, EMA) on CMC topics.
• Coordinate responses to regulatory questions and agency requests.
• Drive cross-functional collaboration in a global matrix.

Skills

Regulatory CMC

Module 3 submissions

Biologics knowledge

ICH FDA EMA

Leadership

Education

Master's degree in Pharmacy

Job description

Excelya is seeking a Senior Regulatory Consultant to deliver strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate (ADC) biologics program. The role requires steering global CMC activities for MAA/BLA submissions, with an emphasis on strategy and matrix-management leadership.

The consultant will interact with global health authorities (FDA, EMA) and guide cross-functional teams to ensure regulatory readiness and lifecycle management of biologics products.