Senior Manager, Global Regulatory Affairs CMC (all genders)

at  Merck Group

Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

As the Senior Manager Regulatory CMC, you will be at the forefront of shaping our regulatory landscape. You will represent the Global Regulatory Affairs CMC group, providing invaluable guidance to internal teams, including Global Regulatory Strategy, CMC, technology transfer, manufacturing launch, and global supply chain. Your expertise will drive all CMC regulatory activities, as you take ownership of the CMC dossier Strategy Document, ensuring the highest quality and strategic decision-making for submissions worldwide. You will lead the development of the Global Regulatory CMC strategy for Life Cycle Management programs, focusing on proactive risk assessment and mitigation. Additionally, you will engage with Health Authorities, interpret country-specific regulatory requirements, and review emerging laws and guidance, positioning us as leaders in a competitive market.