Senior Regulatory Affairs CMC (ADC/Biologics)
Descrizione dell'offerta
Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills 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. Missions Lead 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 requirements to support successful registration and lifecycle management of biologic and ADC products. Requirements About you ! Education : Master’s degree or equivalent in Pharmacy
Dettagli
- Azienda: Excelya
- Sede: Remoto
- Tipo di contratto: Tempo pieno
- Fonte: arbeitnow
- Valido fino al: 5 novembre 2026
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