Senior Regulatory Affairs Lead

3 weeks ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time
About the Role

Genmab is seeking a Senior Manager/Associate Director, EU/ROW Regulatory Lead to join our Global Regulatory Affairs organization.

Key Responsibilities
  • Represent RA in the Clinical Trial Teams and ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.
  • Work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW.
  • Act as EU/ROW Regulatory Lead for assigned projects and be responsible for the development and execution of the EU/ROW regulatory strategy.
  • Lead the preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc.
  • Plan, prepare, and lead EMA or national Scientific Advice procedures, as relevant.
  • Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
  • Monitor and assess regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
About You

We're looking for a highly motivated and dedicated individual who is passionate about our purpose and genuinely cares about our mission to transform the lives of patients through innovative cancer treatment.

You bring rigor and excellence to all that you do and are a fierce believer in our rooted-in-science approach to problem-solving.

You are a generous collaborator who can work in teams with diverse backgrounds and are determined to do and be your best and take pride in enabling the best work of others on the team.

You are not afraid to grapple with the unknown and be innovative and have experience working in a fast-growing, dynamic company or a strong desire to.

You work hard and are not afraid to have a little fun while you do so.



  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleAs a Senior Global Regulatory Affairs Strategic Lead at Genmab, you will be part of our Global Regulatory Affairs organization, playing a crucial role in shaping our regulatory strategy. Based in Copenhagen, Denmark, this hybrid position requires on-site presence 60% of the time.Job DescriptionThis is an exceptional opportunity to lead highly...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe're seeking an experienced Senior Director to lead our Global Regulatory Affairs team. As a key member of our organization, you'll be responsible for developing global strategies to advance our portfolio of development pipeline candidate drugs and marketed products.You'll provide strategic input and ensure operational execution of global...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job SummaryGenmab seeks a highly skilled and experienced Senior Regulatory Affairs Specialist to join its Global Regulatory Affairs organization. As a key member of the team, you will be responsible for developing and executing EU/ROW regulatory strategies for assigned projects. Your expertise in EU regulatory mechanisms and prior experience working with the...


  • Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full time

    Senior Regulatory ScientistWe are seeking a highly skilled Senior Regulatory Scientist to join our team at Voisin Consulting SARL. This role will involve developing and executing regulatory strategies for assigned projects, including the preparation and submission of regulatory filings.Key Responsibilities:Develop and execute regulatory strategies for...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Genmab is a cutting-edge international biotechnology company that strives to improve the lives of patients through innovative antibody therapeutics. With over 20 years of experience, our passionate and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences to create a proprietary...


  • Copenhagen, Copenhagen, Denmark WSAudiology Full time

    At WSAudiology, we're navigating a rapidly evolving regulatory landscape and seeking a Global Senior Regulatory Affairs Specialist to join our team.This pivotal role will ensure that our products meet the highest standards of compliance. As a key member of our global Regulatory Affairs team, you'll be integral to day-to-day regulatory problem-solving and...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly experienced Senior Director to lead our EU/ROW Regulatory Affairs team. As a key member of our Global Regulatory Affairs organization, you will be responsible for developing and implementing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.Key...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Senior Director, Regulatory Affairs Strategy-EU/RoW Genmab is seeking a highly experienced and skilled Regulatory Affairs leader to join our Global Regulatory Affairs organization. This key role will be responsible for the development of global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products. The...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Strategy Director to join our team at Genmab. This is a senior leadership role that will be responsible for developing and implementing regulatory strategies for our EU/ROW programs.The ideal candidate will have a minimum of 10 years of experience in Regulatory Affairs, with expertise in drug...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly experienced and skilled Senior Director, Regulatory Affairs Strategy-EU/RoW to lead our Global Regulatory Affairs organization.Job SummaryThis senior leadership position will oversee the development and implementation of EU/ROW regulatory strategies for assigned programs. The ideal candidate will have significant...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About GenmabGenmab is a pioneering biotechnology company dedicated to developing innovative antibody therapies that transform the lives of patients with cancer and other serious diseases. Our mission is to push the boundaries of science and medicine, and our team is passionate about making a meaningful impact.The RoleWe are seeking a highly skilled and...


  • Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full time

    **About the Role**We are seeking a seasoned Senior Regulatory Scientist to spearhead our regulatory affairs efforts in the Nordic region. This is an excellent opportunity for individuals who thrive in dynamic environments and are passionate about driving innovation in Life Science.**Responsibilities:**Develop and execute regulatory strategies for assigned...


  • Copenhagen, Copenhagen, Denmark Voisin Consulting SARL Full time

    Senior Regulatory Scientist RoleWe are continuing to grow our Nordic business and are now seeking a Senior Regulatory Scientist. This role is suitable for those who are excited at the pace of change and innovation in Life Science, who want to partner with cutting-edge clients and continuously learn, develop, and progress personally and professionally.Key...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking an experienced Senior Director to join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for the EU/ROW regulatory strategy for an assigned program and manage a team of Regulatory Strategists with EU/ROW responsibilities.Key Responsibilities:Regulatory Strategy Development: Develop...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly experienced Senior Director to lead our EU and ROW Regulatory Affairs organization. In this position, you will be responsible for developing and implementing the EU and ROW regulatory strategy for assigned programs, as well as managing a team of Regulatory Strategists.Main ResponsibilitiesDevelop and implement the EU and...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleThe successful candidate will be part of our Global Regulatory Affairs organization, working closely with the Clinical Trial Teams to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW. This role involves representing RA in the Clinical Trial Teams and ensuring the timely and compliant execution of multiple, often...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Transform the lives of patients with innovative cancer treatment by joining our dynamic team at Genmab A/S as a Senior Regulatory Affairs Manager for Biological Products.About the RoleWe are seeking a seasoned professional to lead our regulatory affairs efforts in the CMC department. As a Senior Regulatory Affairs Manager, you will be responsible for...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Transforming Lives through Innovative Cancer TreatmentAt Genmab, we're driven by a passion for improving the lives of patients through innovative and differentiated antibody therapeutics. As a Senior Director, Regulatory Affairs Strategy-EU/RoW, you'll play a critical role in shaping our global regulatory strategies to advance our portfolio of development...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    The RoleAs a Senior Director, Regulatory Affairs Strategy-EU/RoW, you will be responsible for leading the EU/ROW regulatory strategy for assigned programs and managing a team of Regulatory Strategists. This role will involve assuming responsibility for the EU/ROW regulatory strategy for assigned programs and managing a group of Regulatory Strategists with...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking an experienced and passionate leader to join our Global Regulatory Affairs organization as a Senior Director, Regulatory Affairs Strategy-EU/RoW. In this role, you will be responsible for developing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products. You will provide...