Senior Regulatory Affairs CMC (ADC/Biologics)

About the role

Excelya is seeking a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate biologics program. The consultant will lead global Regulatory CMC activities for Marketing Authorisation Applications and Biologics License Applications while managing matrix-leadership responsibilities.

Responsibilities

• Lead and drive the global Regulatory CMC strategy for biologics and Antibody Drug Conjugate programs.
• Provide strategic leadership for global BLA and MAA preparation, submission, and lifecycle management activities.
• Ensure alignment of CMC regulatory strategies with overall product development and commercialization objectives.
• Anticipate regulatory risks and develop proactive mitigation plans.
• Oversee the preparation, review, and finalization of Module 3 CMC content for global submissions.
• Lead interactions with global health authorities, including FDA, EMA, and other international agencies, on CMC-related topics.
• Coordinate responses to regulatory questions, deficiency letters, and agency requests.
• Drive cross-functional collaboration within a global matrix environment, aligning regulatory, technical, and program teams.

Required skills

• Regulatory CMC
• Biologics
• Antibody-Drug Conjugate
• Module 3
• MAA
• BLA
• ICH
• FDA
• EMA
• Regulatory strategy

Qualifications

• Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or a related scientific discipline

About the Company

Excelya is an ambitious healthcare company with more than 900 employees across Europe, aiming to become the leading mid-sized CRO in Europe. They provide an integrated service model combining Consulting, Functional Service Provider, and Full-Service solutions.