Senior Regulatory Affairs CMC (ADC/Biologics)

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Habilidades

and recognizes your value.Our client is looking for a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership support for a global Antibody-Drug Conjugate (ADC) biologics program

The selected consultant will play a critical role in leading global Regulatory CMC activities associated with Marketing Authorisation Applications (MAA) and/or Biologics License Applications (BLA), with a focus on global regulatory CMC strategy and matrix-management leadership.

MissionsLead and drive the global Regulatory CMC strategy for biologics and Antibody Drug Conjugate (ADC) 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.

• Ensure scientific consistency, regulatory compliance, and quality of submission documentation.
• 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.

• Maintain expertise in ICH, FDA, EMA, and international regulatory.

Requisitos

to support successful registration and lifecycle management of biologic and ADC products.RequirementsAbout you ! Education : Master’s degree or equivalent in Pharmacy, Chemistry...