Senior Regulatory Affairs CMC (ADC/Biologics)

• 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.

About you ! Education : Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or a related scientific discipline. Experience : Solid experience in Regulatory CMC within the pharmaceutical industry, strong expertise in Biologics product Skills : Proven hands-on experience leading Module 3 of biologic MAA and/or BLA submissions. Understanding of ICH, FDA, and EMA regulatory requirements applicable to Module 3. Demonstrated experience defining and implementing global regulatory strategies. Langages : Fluent English required

About Excelya At Excelya, we combine a passion for science with a strong team spirit to redefine excellence in healthcare. We are an ambitious healthcare company bringing together more than 900 employees across Europe, with the ambition of becoming the leading mid-sized CRO in Europe, while providing the best possible employee experience. Our integrated service model, combining Consulting, Functional Service Provider (FSP), and Full-Service solutions, gives you the opportunity to work on a wide variety of high-value projects. You will collaborate with recognized experts and make a meaningful contribution to improving the patient journey. At Excelya, caring is at the heart of everything we do. We promote equal opportunities and are committed to building a diverse, equitable, and inclusive working environment where everyone can thrive, be recognized, and fully contribute to a shared mission. Your challenges become our collective mission. Together, we turn ambitious ideas into tangible achievements, the Excelya way. Join us today and become an Excelyate!

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. About you ! Education : Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or a related scientific discipline. Experience : Solid experience in Regulatory CMC within the pharmaceutical industry, strong expertise in Biologics product Skills : Proven hands-on experience leading Module 3 of biologic MAA and/or BLA submissions. Understanding of ICH, FDA, and EMA regulatory requirements applicable to Module 3. Demonstrated experience defining and implementing global regulatory strategies. Langages : Fluent English required About Excelya At Excelya, we combine a passion for science with a strong team spirit to redefine excellence in healthcare. We are an ambitious healthcare company bringing together more than 900 employees across Europe, with the ambition of becoming the leading mid-sized CRO in Europe, while providing the best possible employee experience. Our integrated service model, combining Consulting, Functional Service Provider (FSP), and Full-Service solutions, gives you the opportunity to work on a wide variety of high-value projects. You will collaborate with recognized experts and make a meaningful contribution to improving the patient journey. At Excelya, caring is at the heart of everything we do. We promote equal opportunities and are committed to building a diverse, equitable, and inclusive working environment where everyone can thrive, be recognized, and fully contribute to a shared mission. Your challenges become our collective mission. Together, we turn ambitious ideas into tangible achievements, the Excelya way. Join us today and become an Excelyate!