Director of CMC and Global Regulatory Compliance

About the JobGenmab A/S is seeking an experienced Director/Associate Director, Global Regulatory Affairs to join our Regulatory Affairs team. The successful candidate will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing authorization...

About the RoleAt Genmab, we're pushing the boundaries of antibody therapies to transform lives. As a Director/Associate Director, Global Regulatory Affairs, you'll play a crucial role in shaping our regulatory strategy for biologics.This exciting opportunity requires a seasoned professional with expertise in CMC regulatory affairs, strategic thinking, and...

Job DescriptionThe Regulatory Affairs team at Genmab A/S is seeking an experienced professional to fill the role of Director/Associate Director, Global Regulatory Affairs. The successful candidate will be responsible for providing strategic regulatory guidance on CMC topics, collaborating with cross-functional peers, and planning and preparing CMC...

The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com.Director/Associate Director, Global Regulatory Affairs - CMCAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering...

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...

Job RoleThe Director/Associate Director, Global Regulatory Affairs will provide strategic regulatory guidance on CMC topics, collaborate with cross-functional peers, and plan and prepare CMC documentation for clinical applications, marketing authorization applications, and health authority briefing packages.This role requires strong leadership and...

At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being proudly unique,...

Company OverviewGenmab is an international biotechnology company dedicated to developing next-generation antibody therapeutics. Our team is passionate about improving lives through innovative medicines.We've built a robust pipeline of differentiated antibody platforms, including bispecific T-cell engagers, immune checkpoint modulators, and antibody-drug...

Job Overview:The Senior Director of Global Regulatory Affairs will lead Tbwa Chiat/Day Inc's global regulatory strategy, ensuring compliance with international financial regulations and alignment with business objectives. This role involves overseeing the company's engagement with regulatory bodies, shaping public policy initiatives, and ensuring seamless...

The Regulatory Director will serve as a key regional leader for the company's regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing the unique requirements of local markets. Acting as a bridge between the VP of Public Policy & Regulatory Affairs, other Regional Regulatory Directors, and local teams, this...

Our Regulatory Affairs organization plays a critical role in ensuring the successful development and approval of our innovative antibody products and therapies. As our Senior Manager EU/ROW Regulatory Affairs, you'll have the opportunity to make a significant impact on our regulatory strategy and compliance efforts.You'll work closely with cross-functional...

Regulatory Director Job DescriptionTbwa Chiat/Day Inc is seeking a highly experienced and skilled Regulatory Director to join our team. This key regional leader will play a crucial role in shaping our regulatory strategy and compliance framework, ensuring alignment with global objectives while addressing local market nuances.The ideal candidate will have...

We are looking for a Senior CMC Project Manager to join our Global CMC-Development team at ALK-Abelló A/S. As a key member of the team, you will be responsible for managing projects in different phases, including pre-clinical, clinical phase III preparations, and Life Cycle Management/optimization projects.Your key responsibilities will include:Leading...

Job OverviewTbwa Chiat/Day Inc is a leading company in the fintech industry, and we are seeking a Regulatory Director to lead our regulatory strategy and compliance efforts.This role requires a highly skilled and experienced professional who can analyze complex regulatory changes, provide guidance on compliance matters, and develop strategic plans to ensure...

About the Role:The Associate Director Regulatory Strategy will be responsible for developing and executing the EU/ROW regulatory strategy for assigned projects. This role will represent EU/ROW in the Global Regulatory Team(s) and work closely with CROs and internal stakeholders to ensure compliance with regulatory requirements.Key Responsibilities:Develop...

The Senior Director of Global Regulatory Affairs plays a critical role in ensuring Tbwa Chiat/Day Inc's compliance with international financial regulations and alignment with business objectives. This requires developing and overseeing the company's global regulatory strategy, ensuring seamless collaboration between regulatory and legal teams across regions,...

Get AI-powered advice on this job and more exclusive features. Senior Business Development Consultant at Black Swans Exist Director of Regulatory Affairs Are you ready to take on a pivotal role in shaping the future of women's health? Our client, a clinical-stage biotech company revolutionizing microbiome-based therapies for women's reproductive health,...

Job DescriptionThe Director of CMC will lead the development and implementation of CMC strategies, ensuring manufacturing, supply chain, and Quality Management Systems align with the company's overall strategic objectives. Responsibilities include:Developing Technical Operations strategies for early and late-phase drug development in collaboration with...

Regulatory Affairs Expertise for a Leading Biotech CompanyWe are seeking a highly experienced and skilled Director of Regulatory Strategy and Operations to join our team at Genmab A/S. As a key member of the Global Regulatory Affairs organization, you will play a critical role in shaping the company's regulatory strategies and ensuring the successful...

We are looking for an exceptional individual to join our team as an Associate Director, Global Regulatory Affairs Project Lead. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring regulatory compliance and oversight for our clinical trials.In this role, you will represent RA in Clinical Trial Teams and...